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.
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