Drug product
Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000 count bottles (NDC 42937-704-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.
D-0166-2017
Product summary
- Event
- Event 75655
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,514,500 tablets
- Official record key
drug-enforcement:D-0166-2017
Official wording
Reason: CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Code information: Lot #: a) 28141502, 28141503, 28141504, 28141505, 28141506, Exp 03/17; 28141507, Exp 09/17; 28141508, 28141510, 28141511, Exp 10/17; b) 28141502, 28141504, 28141506, Exp 03/17; 28141507, Exp 09/17; 28141508, 28141510, 28141511, Exp 10/17; c) 28141501, 28141502, 28141504, 28141506, Exp 03/17; 28141507, Exp 09/17; 28141508, 28141510, 28141511, Exp 10/17
Distribution pattern: Nationwide in USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations