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
FDA recall notice · announced August 7, 2019 · American Health Packaging
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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
Reason for recall
Failed Dissolution Specifications: Out of specification result for the dissolution test.
Notes
Distribution: Nationwide in the USA
Lot/code information: Lot 172569, Exp 7/31/2019
Quantity: 6,579 cartons
Status: Terminated
Products in this recall event:
- 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 Un (D-1582-2019)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.