Drug product
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.
D-0168-2017
Product summary
- Event
- Event 75655
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,786,653 tablets
- Official record key
drug-enforcement:D-0168-2017
Official wording
Reason: CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Code information: Lot #: 28181501, 28181502, Exp 03/17; 28181503, 28181504, Exp 08/17; 28181505, 28181506, Exp 09/17; 28181601, Exp 01/18
Distribution pattern: Nationwide in USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations