Drug product
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11
D-1582-2019
Product summary
- Event
- Event 83466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,579 cartons
- Official record key
drug-enforcement:D-1582-2019
Official wording
Reason: Failed Dissolution Specifications: Out of specification result for the dissolution test.
Code information: Lot 172569, Exp 7/31/2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification