Why it was 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.
Product description
minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30.
Lot numbers, UPCs & expiration codes
lot # T2300765- exp. 11/30/2025 lot# T2201702A-exp. 02/28/2025 lot# T2201699- exp. 2/28/2025 lot# T2201698- exp. 2/28/2025
Where it was sold
US Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0474-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 23, 2024
- FDA report date
- May 1, 2024
- Quantity
- 12808 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- EPI Health, LLC
Original FDA data
Every field from FDA enforcement report D-0474-2024, exactly as published.
Show all FDA fields
- City
- Charleston
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 94447
- Address
- 174 Meeting St Ste 200
- Code information
- lot # T2300765- exp. 11/30/2025 lot# T2201702A-exp. 02/28/2025 lot# T2201699- exp. 2/28/2025 lot# T2201698- exp. 2/28/2025
- Postal code
- 29401-3211
- Report date
- May 1, 2024
- Product type
- Drugs
- Recall number
- D-0474-2024
- Classification
- Class II
- Recalling firm
- EPI Health, LLC
- Product quantity
- 12808 bottles
- Termination date
- Sep 12, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30.
- Distribution pattern
- US Nationwide
- Recall initiation date
- Apr 23, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 25, 2024