The Recall Desk
ModerateFDA (Drugs)·D-0485-2023·Announced 2023-04-05

Simvastatin 20mg Tablets Recalled for Manufacturing Practice Deviations

Direct Rx recalled Simvastatin 20mg tablets nationwide due to manufacturing practice deviations. The voluntary recall affects bottles distributed across the United States.

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: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is manufacturing process-related without specific documented harm. Per the rubric, voluntary precautionary recalls without reported adverse events qualify as Moderate (Score 2).

Plain-English summary

Direct Rx has initiated a recall of Simvastatin, USP, 20 mg Tablets (prescription only) distributed nationwide in the United States. The recalled products are available in 30-count bottles (NDC 61919-0446-30) and 90-count bottles (NDC 61919-0446-90) with various lot numbers and expiration dates.

The recall was issued due to manufacturing practice deviations, specifically violations of current good manufacturing practice (cGMP) standards identified at the manufacturing facility.

Persons who have dispensed or received affected lots should check the lot number and expiration date against the list provided by the FDA. Healthcare providers should determine the appropriate course of action with their patients regarding this medication.

The recall was voluntarily initiated by the firm on March 13, 2023, and was terminated on June 17, 2024. The FDA classified this as a Class II recall.

The recalled product

Product
Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Manufacturer
Direct Rx
Category
Drug
Hazard
  • manufacturing-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 (20)

  • a) [30-count bottles] Lot
  • expiry: 09JA2312
  • exp 2/28/2025
  • b) [90-count bottles] Lot
  • expiry: 22OC2111
  • exp 1/31/2023
  • 13OC2120
  • exp 3/31/2023
  • 16JY2104
  • exp 12/31/2023
  • 09AU2125
  • exp 1/31/2024
  • 28JY2125
  • 23SE2115
  • exp 3/31/2024
  • 07JA2211
  • exp 5/31/2024
  • 27JA2214
  • 15AP2224
  • exp 6/30/2024

Distribution

Distributed nationwide across the United States.

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