Drug product
Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04
D-1026-2018
Product summary
- Event
- Event 80659
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,161 Cartons
- Official record key
drug-enforcement:D-1026-2018
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot: 71545AA, exp 7/2019
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications