Drug product
Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.
D-1274-2020
Product summary
- Event
- Event 85555
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68,376 bottles
- Official record key
drug-enforcement:D-1274-2020
Official wording
Reason: Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Code information: Lot #: a) 71846B, Exp 6/2021; b) 71726A, Exp 6/2020; 71846B, 71853A, Exp 6/2021
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
out of specification