Drug product
Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC Middlesex, NJ 08846, NDC 64720-128-10
D-1079-2014
Product summary
- Firm
- Corepharma LLC
- Event
- Event 67291
- Status
- Terminated
- Classification
- Class II
- Quantity
- 174,888 Bottles
- Official record key
drug-enforcement:D-1079-2014
Official wording
Reason: 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.
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
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification