D-1062-2013 Class II Terminated
FDA drug recall D-1062-2013 was initiated by Core Pharma Llc on July 2, 2013 and is designated Class II. Reason for recall: Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing. The recall status is terminated (terminated August 25, 2014). Affected quantity: 960 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 2, 2013
- Initiation Date
- July 2, 2013
- Termination Date
- August 25, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 960 bottles
Product Description
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
Reason for Recall
Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.
Distribution Pattern
Nationwide
Code Information
109497; Exp. 12/15