The Recall Desk
ModerateFDA (Drugs)·D-0480-2023·Announced 2023-04-05

Drug Recall: Glimepiride Tablets Due to Manufacturing Deviations

Direct Rx is recalling Glimepiride, USP, 1 mg Tablets nationwide due to cGMP deviations. The firm-initiated recall impacts both 30-count and 90-count bottles distributed across the USA.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II FDA recall involving cGMP deviations detected during manufacturing. It is a voluntary, firm-initiated recall with no reported illnesses or injuries mentioned in the source. Without identification of a specific hazard outcome and given the voluntary and precautionary nature, this falls into the Moderate category per the severity rubric.

Plain-English summary

Direct Rx is voluntarily recalling Glimepiride, USP, 1 mg Tablets distributed nationwide due to current good manufacturing practice (cGMP) deviations. The affected product includes 30-count bottles (NDC 61919-0723-30) and 90-count bottles (NDC 61919-0723-90), with specific lot numbers and expiration dates documented in the recall notice.

The firm identified the manufacturing deviation and initiated a voluntary recall on March 13, 2023. Direct Rx, based in Dawsonville, Georgia, reported the issue to the FDA. The recall involves 4 bottles of the 30-count package and 172 bottles of the 90-count package distributed across the United States.

Patients should check the lot number and expiration date printed on their medication bottle to determine if it is part of the recalled product. Individuals with affected medication should contact their pharmacist or healthcare provider for further guidance.

The recalled product

Product
Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Manufacturer
Direct Rx
Category
Drug
Hazard
  • gmp-deviation

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 (13)

  • a) [30 count bottles] Lot
  • expiry: 07MA2208
  • exp 5/31/2024 b) [90 count bottles] Lot
  • expiry: 09AU2128
  • exp 1/31/2024
  • 28JY2102
  • 06AU2103
  • 03JA2210
  • 14JY2114
  • 05NO2106
  • exp 2/29/2024
  • 13OC2118
  • 08DE2121

Distribution

Distributed nationwide across the United States.

Related recalls

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