The Recall Desk
ModerateFDA (Drugs)·D-0484-2023·Announced 2023-04-05

Drug Manufacturer Recalls Simvastatin Tablets for Manufacturing Deviations

Direct Rx recalled Simvastatin 10 mg tablets nationwide due to manufacturing process deviations discovered during production. No illnesses or injuries have been reported.

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 or injuries and manufacturing process deviations. This voluntary, firm-initiated precautionary recall falls under the Moderate category per the rubric criteria for voluntary recalls without reported harm.

Plain-English summary

Direct Rx is recalling Simvastatin, USP 10 mg tablets that were distributed nationwide. The medication is available in 30-count and 90-count bottles under FDA approval as a prescription-only drug.

The recall was initiated voluntarily by Direct Rx due to cGMP deviations—manufacturing process violations related to current Good Manufacturing Practice standards. These standards ensure the quality and safety of pharmaceutical manufacturing.

Patients in possession of affected bottles should contact their pharmacy or healthcare provider to verify if their medication is part of the recall using the lot and expiration date information. No illnesses or injuries have been reported in connection with this product. The FDA classified this as a Class II recall.

The recalled product

Product
Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Manufacturer
Direct Rx
Category
Drug
Hazard

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 (12)

  • a) [30-count bottles] Lot
  • expiry: 05AU2206
  • exp 10/31/23
  • b) [90-count bottles] Lot
  • expiry: 30MA2213
  • exp 6/30/23
  • 10DE2124
  • exp 3/31/23
  • 15MA2224
  • exp 5/32/23
  • 27JA2229
  • exp 3/31/23.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Direct Rx under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

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