D-1582-2019 Class II Terminated
FDA drug recall D-1582-2019 was initiated by American Health Packaging on Aug 1, 2018 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Out of specification result for the dissolution test. The recall status is terminated (terminated Sep 30, 2020). Affected quantity: 6,579 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 7, 2019
- Initiation Date
- Aug 1, 2018
- Termination Date
- Sep 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,579 cartons
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot 172569, Exp 7/31/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1582-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026