D-1293-2020 Class II Terminated
FDA drug recall D-1293-2020 was initiated by American Health Packaging on May 19, 2020 and is designated Class II. Reason for recall: Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life). The recall status is terminated (terminated August 3, 2022). Affected quantity: 15,755 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- June 17, 2020
- Initiation Date
- May 19, 2020
- Termination Date
- August 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,755 cartons
Product Description
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
Reason for Recall
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Distribution Pattern
USA Nationwide
Code Information
Lots 179605, Exp 06/30/2020; 181105, Exp 08/31/2020; 183019, Exp 01/31/2021