FDA-Drug2019-10-02Class III

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.

EPI Health, LLC
Hazard

Failed Dissolution Specifications:

Sold states
Firm recalling only from EPI Field Representatives.
Affected count
1,626 5-count bottles
Manufactured in
134 Columbus St, Charleston, SC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0120-2020

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