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.
Reported: May 1, 2024 Initiated: April 23, 2024 #D-0475-2024
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.
Details
- Recalling Firm
- EPI Health, LLC
- Units Affected
- 5664 bottles
- Distribution
- US Nationwide
- Location
- Charleston, SC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by EPI Health, LLC. Units affected: 5664 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 1, 2024. Severity: Moderate. Recall number: D-0475-2024.
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