The Recall Desk
LowFDA (Drugs)·D-0120-2020·Announced 2019-10-02

EPI Health Recalls Minolira Tablets for Dissolution Failures

EPI Health is recalling 1,626 bottles of Minolira extended-release tablets because they failed dissolution specifications. The recall is limited to EPI field representatives.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

EPI Health, LLC is recalling 1,626 five-count bottles of Minolira (minocycline hydrochloride) extended-release tablets, 135 mg. The product is identified by Lot # T900093 and an expiration date of 11/2020. The recall is being conducted because the tablets failed to meet dissolution specifications.

The recall is limited to EPI field representatives. The source text does not indicate that the product was distributed to retail pharmacies or directly to consumers. Minolira is a prescription-only medication manufactured by Dr. Reddy's Laboratories Limited in India for EPI Health, LLC.

Consumers who may have obtained these specific physician samples should contact their healthcare provider or EPI Health for further instructions. The recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.

The recalled product

Product
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
Manufacturer
EPI Health, LLC

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot# T900093
  • Exp 11/2020

Distribution

Distribution scope not specified by the agency.