Why it was recalled
Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.
Product description
Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC Middlesex, NJ 08846, NDC 64720-128-10
Lot numbers, UPCs & expiration codes
Lot #s and Exp dates: 106019 exp December-13 106020 exp December -13 106336 exp January-14 106337 exp January-14 106338 exp January-14 106097 exp February-14 106098 exp February-14 106099 exp February-14 106100 exp April-14 106545 exp April-14 106664 exp April-14 107208 exp July-14 107363 exp October-14 107574 exp October-14 107629 exp October-14 108167 exp February-15 108168 exp February-15 108169 exp February-15 108322 exp May-15
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1079-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 13, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 174,888 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Corepharma LLC
Original FDA data
Every field from FDA enforcement report D-1079-2014, exactly as published.
Show all FDA fields
- City
- Middlesex
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 67291
- Address
- 215 Wood Ave
- Code information
- Lot #s and Exp dates: 106019 exp December-13 106020 exp December -13 106336 exp January-14 106337 exp January-14 106338 exp January-14 106097 exp February-14 106098 exp February-14 106099 exp February-14 106100 exp April-14 106545 exp April-14 106664 exp April-14 107208 exp July-14 107363 exp October-14 107574 exp October-14 107629 exp October-14 108167 exp February-15 108168 exp February-15 108169 exp February-15 108322 exp May-15
- Postal code
- 08846-2554
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1079-2014
- Classification
- Class II
- Recalling firm
- Corepharma LLC
- Product quantity
- 174,888 Bottles
- Termination date
- Jan 29, 2015
- Reason for recall
- Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC Middlesex, NJ 08846, NDC 64720-128-10
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Dec 13, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 5, 2014