Drug product
Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10
D-1062-2013
Product summary
- Firm
- Core Pharma Llc
- Event
- Event 65889
- Status
- Terminated
- Classification
- Class II
- Quantity
- 960 bottles
- Official record key
drug-enforcement:D-1062-2013
Official wording
Reason: Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.
Code information: 109497; Exp. 12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification