PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 17, 2020 Initiated: May 19, 2020 #D-1293-2020

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).

Details

Recalling Firm
American Health Packaging
Units Affected
15,755 cartons
Distribution
USA Nationwide
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
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. Recalled by American Health Packaging. Units affected: 15,755 cartons.
Why was this product recalled?
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Which agency issued this recall?
This recall was issued by the FDA Drug on June 17, 2020. Severity: Moderate. Recall number: D-1293-2020.