Why it was recalled
Failed Dissolution Specifications:
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.
Lot numbers, UPCs & expiration codes
Lot# T900093, Exp 11/2020
Where it was sold
Firm recalling only from EPI Field Representatives.
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-0120-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 26, 2019
- FDA report date
- Oct 2, 2019
- Quantity
- 1,626 5-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- EPI Health, LLC
Original FDA data
Every field from FDA enforcement report D-0120-2020, exactly as published.
Show all FDA fields
- City
- Charleston
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 83809
- Address
- 134 Columbus St
- Code information
- Lot# T900093, Exp 11/2020
- Postal code
- 29403-4809
- Report date
- Oct 2, 2019
- Product type
- Drugs
- Recall number
- D-0120-2020
- Classification
- Class III
- Recalling firm
- EPI Health, LLC
- Product quantity
- 1,626 5-count bottles
- Termination date
- Aug 18, 2021
- Reason for recall
- Failed Dissolution Specifications:
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Firm recalling only from EPI Field Representatives.
- Recall initiation date
- Aug 26, 2019
- Initial firm notification
- Center classification date
- Oct 2, 2019