Drug product
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11
D-1293-2020
Product summary
- Event
- Event 85745
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,755 cartons
- Official record key
drug-enforcement:D-1293-2020
Official wording
Reason: Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Code information: Lots 179605, Exp 06/30/2020; 181105, Exp 08/31/2020; 183019, Exp 01/31/2021
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Failed dissolution specification