D-0475-2024 Class II Terminated
FDA drug recall D-0475-2024 was initiated by EPI Health, LLC on April 23, 2024 and is designated Class II. Reason for recall: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented… The recall status is terminated (terminated September 12, 2024). Affected quantity: 5664 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2024
- Initiation Date
- April 23, 2024
- Termination Date
- September 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5664 bottles
Product Description
minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-102-30.
Reason for Recall
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Distribution Pattern
US Nationwide
Code Information
lot# T2201700- exp. 02/28/2025 lot# T2201701- exp. 02/28/2025