Drug product
Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.
D-1025-2018
Product summary
- Event
- Event 80364
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29048 500-count bottles (14,524,000 tablets)
- Official record key
drug-enforcement:D-1025-2018
Official wording
Reason: Failed Dissolution Specifications:
Code information: Lot# 71545A, Expiry date: 07/19
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications