Status
Terminated
Drug Enforcement D-1062-2013
Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.
Classification
Class II
Report Date
October 2, 2013
Termination Date
August 25, 2014
Product Information
- 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
- Product quantity
- 960 bottles
- Reason for recall
- Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Core Pharma Llc
- Address
-
215 Wood Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1062-2013
- Event ID
- 65889
- Recall initiation date
- July 2, 2013
- Center classification date
- September 20, 2013
- Code info
- 109497; Exp. 12/15
- More code info
- —