Drug product
Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.
D-0165-2017
Product summary
- Event
- Event 75655
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,882,661 tablets
- Official record key
drug-enforcement:D-0165-2017
Official wording
Reason: CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Code information: Lot #: a) 28121501, 28121502, 28121503, 28121504, Exp 03/17; 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17; b) 28121503, 28121504, Exp 03/17; 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17; c) 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17
Distribution pattern: Nationwide in USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations