PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: October 2, 2019 Initiated: August 26, 2019 #D-0120-2020

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:

Details

Recalling Firm
EPI Health, LLC
Units Affected
1,626 5-count bottles
Distribution
Firm recalling only from EPI Field Representatives.
Location
Charleston, SC

Frequently Asked Questions

What product was recalled?
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.. Recalled by EPI Health, LLC. Units affected: 1,626 5-count bottles.
Why was this product recalled?
Failed Dissolution Specifications:
Which agency issued this recall?
This recall was issued by the FDA Drug on October 2, 2019. Severity: Low. Recall number: D-0120-2020.