Drug product
Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152.
D-1288-2020
Product summary
- Event
- Event 85757
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,443 cartons
- Official record key
drug-enforcement:D-1288-2020
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) R00828D, Exp. date 08/2020, b) R00732D, Exp. date 05/2020; R00783D, Exp. date 06/2020; R00827D, Exp. date 08/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
out-of-specification