Amneal Pharmaceuticals Hydrocodone 10-325 (Page 3)

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I have been taking hydrocodone 10-325 (made by Watson) for about a year. I picked up my prescription yesterday and instead of the normal yellow pill, I received a white oblong pill imprinted with m367 on it. I took 2 for breakthrough pain and had no relief what-so-ever. I called the pharmacy and was told that they will no longer be able to get the med from Watson. Does anyone know what has happened? I have chronic pain, and these white ones from Amneal Pharmaceuticals is not going to cut it. Has anyone else experienced this?

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41

Please see the letter below that I received from Amneal pharmaceuticals! Hope this helps!

Dear Lynn,

Amneal acknowledges the below and will process accordingly as per our requirements. Amneal has initiated an adverse event investigation under Amneal case number COMP_2018_0049. To successfully conduct/complete this investigation, we are kindly requesting you to further provide us with the following information:

Product/problem Information: (any if available with you):
• Contact information of the dispensing pharmacy (Walgreens) and your permission to contact them to obtain NDC number, lot number and expiration date of the product in question
• Quantity received and prescription number

AE Information:
• Age, date of birth, weight, race, allergies (if any), existing medical conditions (if any), and list of medical products taking (if any), any smoking habits, alcohol use, and any recreational drug use.
• Date you started the Amneal prescription and the date stopped taking this prescription (if applicable), along with the indication this drug was prescribed.
• Date (approximate time period if exact date is unknown) when started noticing the problem.
• Dose and frequency

Treatment and Outcome information: Please advise whether or not you have notified your physician regarding your experience. If yes, please provide us the feedback regarding the recommendation(s) that you may have received from your physician (if any).
• If this report involves an Emergency Room visits/Hospitalization, kindly provide a copy of the medical reports that might have been generated for this visit.
• If the drug was discontinued due to the event please advise the outcome of the event(s) - whether or not the event(s) stopped after drug discontinued.
• If the drug was re-started please advise the outcome of the event(s) - whether or not the event(s) re-appeared after drug was re-started.
• The final outcome/current status for the reported reactions below. (such as recovered, recovering, not recovered, unknown)

Sample return information: Please advise whether you have a sample of the product in question available with you and the likelihood of providing us with a sample, since we would like to have them evaluated by our quality control laboratory. Please notify us accordingly whether or not a sample can be provided. If available for return, we will provide a UPS prepaid mailer to your mailing address for this. Please advise your mailing address.

Any information provided to this file will be handled with confidentiality as per the regulations and will assist us to effectively complete this investigation and will be reporting this occurrence to the FDA’s Adverse Event Reporting System (FAERS). Upon completion of this report, a response letter will be sent to your attention with the findings of this investigation.

Should you have any further questions or concerns, please do not hesitate to contact us.

Sincerely,

Ashwini Patil | Drug Safety Specialist | Amneal Pharmaceuticals of New York |

50 Horseblock Road | Brookhaven, New York 11719 |

631-656-5063 main | 631-952-0214 ext. 3794 direct | 631-924-5145 fax

[email protected]

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42

Yes, I'm stuck right there with the rest of you as far as Watson not being available is concerned. I have far more nasty things to say but won't. It might say Hydrocodone/apap 10-325 but with some of these generics that are out now, I DON'T BELIEVE IT. I heard they are cutting back Hydrocodone content to our veterans because of overdosing or some other crap. If you gave these wounded warriors the care they really needed in some cases for extreme and chronic pain why are they overdosing to try and relieve it? They are also suffering from PTSS and need help! However, what did our WW2 and Vietnam vets do with the same problems? Oh, that's right, they didn't have these bastards in gov't. regulating everything you took then. There was some pretty good stuff around then. What are the Bushes, CIA and their poppy fields in Afghanistan going to do? If we've got such a bad problem with drugs why are those who need them having such a hard time? The gov't. wants to kill off the seniors so take their meds away and give them garbage that doesn't work or makes you far worse like these blood pressure warehouses pumping out lies, hoaxes, poison and selling more crap than they ever have. Just look at who advertises on every T.V. network and propaganda news outlets in the U.S. Hell, if that's not good enough they fly over your damn houses with chem-trails so why do you care if we get the pain relief we need you hypocrites. Go after the Bushes and Clintons and leave the rest of us the hell alone! And keep your stuff away from the kids. Do you really think they are stupid?

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43

I recently required an increase in dose for the Norco to the 10/325. While I’m not thrilled with taking it to begin with it’s the best temporary antidote to control pain. I started with the manufacturer Activas aka Watson, however they’ve been bought out. Part of the generic manufacturing went to Teva yet since they already manufactured the same exact medication it was outsourced. Not sure who to. When I submitted a refill script, I was unaware that the manufacturers had changed as the pharmacist did not discuss this with me when I picked it up. The first dose caused nothing but headaches, I notified the pharmacist immediately who stated there could be a drug allergy. Since this was all I had, I took another dose the following day, before bed-didn’t feel side effects while asleep! The 3rd dose on the next day I noticed I felt no relief, yet 2hrs after I took the dose I began to feel the effects- nausea On the 4th day and my last and final dose, I took the medication at 12:30pm. It was not until 3:55 pm I began to feel the effects (as if it was time released) I was literally sick to my stomach, nauseated with Headaches and still in pain! for 8+hrs after taking a 12:30 does this stuff was still lingering in my body! My resolution: I called my insurance company to notify them I had an adverse reaction to the Amneal manufactured product, I called Walgreens and notified the pharmacist (Mgr) of the same, they refunded my co-pay, I took the unused portion of the prescription to my physician, obtained a receipt for the return and was thankfully given a new RX. I have also stated a formal complaint against the pharmaceutical company which obligates them to check the formulation. Generic manufacturers are required to have them of course approved by the FDA however the excipients or fillers they use in addition to the Tylenol and Hydrocodone varies from one manufacturer to another.
Lastly when I called my local Walgreens to thank them for all their help they stated I was one of 100+ calls in the last week with the similar complaints of illness, so much that it’s been escalated to Executive Mgmt that Amneal’s formulation is causing high amounts of adverse reactions. I advise anyone if they haven’t taken this formulation before from Amneal, don't.

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44

The AMNEAL Norco 10-325 tablets are imprinted with IP 110. I think you are using something from another manufacturer.

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45

Re: Paul (# 44) Expand Referenced Message

No, it's definitely Amneal MFG. It's print is IP110, oblong with score in middle! If I could post picture I would,I am sure!!! Thx!

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46

Patti (# 43) -

Hello Patti, same side effects here too!! Thought maybe given time, would change but been 11 days now & then I remembered, tried this before, several years ago!!! I have & will again contact amneal about this particular product, as should anyone else, having bad side effects! Always let your doctor know too!! Thx!

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47

Re: Lynn (# 46) Expand Referenced Message

Thanks for the reply Lynn. I attempted to contact Amneal by phone for 2days. The phone just rang till it cut off. I was transferred twice by the operator and went to never never land and was given a phone number that didn’t work! I reported it to the FDA and asked the pharmacy to do so as well. I am 1 of 100 people in the course of a week that had similar adverse complaints from the same store for the same medication. I was prescribed Mallinckrodt which is great!

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48

Re: Paul (# 44) Expand Referenced Message

Yes it’s correct- Amneal is Ip110 the bottle reflects the manufacturer as Amneal with confirmation from Walgreens of the recent change in manufacturers.

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49

I have had enough!! Any of you, if it's not too difficult, if you are being prescribed pain medicine, when you go to the pharmacy, check your pharmacy script to see if the manufacturer is Amneal. If it is, give it back to the pharmacist and ask for a different brand. If all they carry is Amneal give it back in return for your script and go to another pharmacy that doesn't carry Amneal. If we can get this garbage off the shelves by refusing it for something else we will get this lousy medicine off the shelves! We won't be lining their pockets with money in return for our health! I will NEVER accept this garbage medicine again!! Always ask before you take it. The pharmacists don't tell us when manufacturers are changed so we trust them and buy it sight unseen and then not find out until later after we've opened the bag. Then we are stuck with this s***ty medicine because we cant return it. I think it is an underhanded practice. I WILL ALWAYS ask about my medicine right there at the pharmacy before I accept this. I hate Amneal's Lortab 10/325!! By underbidding other companies on the market they are trying to get the monopoly of the pharmacies to buy this s***. Lets all be proactive and be aware and refuse this garbage and get another brand if we can.

I know it may not be easy but the more people that do this the better. It's not easy for me to get around but I am going to do this. I won't be getting my pain meds anymore from them. They went from Watson to Amneal because it's cheaper. It's cheaper because it's garbage!! I have been thinking about what happened to me with this last week and I am still very mad!! I am stuck with a s***ty medicine that doesn't work! I wanted name brand and was told by the pharmacist that Lortab is not being made anymore. WHAT! I HATE THE GENERICS!! The generics are what the pharmacies are pushing because they are cheaper. Of course they are cheaper!! Their quality is very sub par!! It's all about money and profits! I hate it! Greedy companies! Why not care about the quality of life for people who need pain meds? Disgusting greedy companies!

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50

Re: Kimber (# 49) Expand Referenced Message

It is best to tell the pharmacist you do not want Amneal before it is filled. Or call the pharmacy and ask the pharmacist if they have other manufacturers besides Amneal before going.

If your Pain Contact states you have to use one pharmacy. Be sure and contact your doctor when you change pharmacies.

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51

I am experiencing the same plus lots of other negative reactions from this garbage medicine!! I have itching, ringing ears, upset stomach, diarrhea, major anxiety, sneezing- all symptoms of opiate withdrawal. Its clear Amneal is not putting the correct amount of pain relief in these pills and they are cutting the price so all the pharmacies are buying this s*** to save money. This makes me so dam mad! I am going to find someone to analyze the ingredients of this s***! If it comes out like I think, there is going to be action. These creeps dont care about the pain people suffer. Its all about profit. Keep these India based pharm companies out of our country and out of business. Selling their s*** to us!! I have chronic pain and I know my body so well I know that this 10/325 by Amneal is total crap!!

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52

Re: BL (# 50) Expand Referenced Message

I did tell the pharmacist and its in my file. They knew I cant take this Amneal. I made it perfectly clear. It makes me mad that they did not bother to tell me the brands changed. Any time a pharmacy changes brands it should be MANDATORY that they inform the consumer BEFORE the prescription is filled so it gives the consumer a chance to get different medicine elsewhere. They took my choice away by not telling me! That is so wrong! They dont want to lose their profit. They dont care if I get sick from this medicine! Its all about the money! Its dispicable!!

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53

Re: Patti (# 47) Expand Referenced Message

We need to get the word out that the Amneal brand 10/325 is garbage! I am happy to hear other people have noticed and are filing complaints too! I would like to have one of my pills analyzed to see what it is really made of!!

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54

Re: Kimber (# 53) Expand Referenced Message

Well amneal wants all my info, I mean all! I sent an email back, explaining under HIPPA, they weren't entitled to that info! Wants me to send a pill to them, etc... I told them enough info to get the lot # & NDC # & what pharmacy, date, etc... I will tell you now, they do not care!! So I am changing pharmacies & thank goodness, I have an awesome female PCP! You see, I maintain on a very low dose, yes I am in pain everyday, but I hate taking meds!! It's enough to take the edge off! I am taking supplements that help a lot! I do a lot of research & cross referencing & check with my PCP before I start anything!! In fact, I am going to see if I can get my doctor to send a sample of amneal to do an independent analysis!!! Will keep you posted!

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55

Re: Lynn (# 54) Expand Referenced Message

I know. They were jerks to me too! Why send them a pill. It should already be documented! I am thinking about taking a pill to a lab NOT associated with Amneal to get the results. Why send it to them? So they can say its ok? I dont think so! They gave me the same run around. They dont care!! Just like you said!!

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56

Re: Kimber (# 49) Expand Referenced Message

I did the same thing after my experience with Amneal I called the other pharmacy”s Walgreens was the only one in the area that switched to Amneal.

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57

Re: Lynn (# 54) Expand Referenced Message

Hi Lynn and Kimber

I called Amneal for 2days and the phone just rang and rang and then the call dropped. Finally got to VM once via the operator yet didn’t get a response . I submitted a Complaint to the FDA. I then sent Amneal a copy of the compliant and hmmmm they called me 1st thing Monday morning. I gave them the info they wanted, didn’t go into details of my personal data tho. They asked if I still had the meds, which is customary yet I swapped it out with my doctor for a new script. I told them Walgreens had plenty on the shelf. I trust Walgreens submmited a complaint as I was 1 of 100+ people from my pharmacy that callled in with similar symptoms we all share. If the FDA gets multiple consumer and pharmacy complaints they will be at Amneal ASAP. The FDA does not take it lightly when the pharmaceutical companies are producing drugs that are resulting in illness

Rite Aid and Walmart, at least in CA use a manufacturer distributed thru Mallinckrodt, I believe it may be Watson, from what Walmart state, much better alternative

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58

Re: Patti (# 57) Expand Referenced Message

Thank you Patti! Im going to contact the FDA. Do you have the info I need so I can talk to the same person you did? I want to get Amneal out of here!! Its obvious they are shady and have something to hide!! They played the same phone games with me!! It makes me feel like its run out of someones garage!! Professional companies done behace this way!!
Thank you so much for getting on the case too!!

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59

Kimber (# 52)

Most pharmacists do not pay attention to things like that. Even if it is really noted on your profile. Which I seriously doubt. They only have Allergic Reactions flagged on profiles. If you have not had an Allergic Reaction that required going to the hospital. Do not expect them to list that on your profile. If you tell the pharmacist you had to go to the hospital. The pharmacist might verify with your doctor.

You might want to talk to your doctor about him writing a Specific Generic Manufacturer on your prescription AND checking or writing Selection Not Permitted. That way, the pharmacy has to fill your prescription with the Generic Manufacturer your doctor writes. Of course, if they do not have that specific Generic Manufacturer you cannot have it filled for another generic of your choosing.. You will have to wait for them to get it in. Or find a pharmacy that carries that Generic Manufacturer.

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60

Re: BL (# 59) Expand Referenced Message

Thanks, I am really sick with this amneal product!! I mean nausea & cramps. I am weak. Calling my doctor in the am!! Uuhhgg!!!!

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