D-0120-2020 Class III Terminated
FDA drug recall D-0120-2020 was initiated by EPI Health, LLC on Aug 26, 2019 and is designated Class III. Reason for recall: Failed Dissolution Specifications: The recall status is terminated (terminated Aug 18, 2021). Affected quantity: 1,626 5-count bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Oct 2, 2019
- Initiation Date
- Aug 26, 2019
- Termination Date
- Aug 18, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,626 5-count bottles
Product description
minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only, Mfg by: Dr. Reddy's Laboratories Limited, FTO-SEZ, Process Unit-01 Devunipalavalasa Village Srikakulam (District) Andhra Pradesh, INDIA. Manufactured for: EPI Health, LLC 134 Columbus St. Charleston, SC 29403 USA. NDC 71403-102-05.
Reason for recall
Failed Dissolution Specifications:
Distribution pattern
Firm recalling only from EPI Field Representatives.
Code information
Lot# T900093, Exp 11/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0120-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026