The Recall Desk
ModerateFDA (Drugs)·D-0486-2023·Announced 2023-04-05

Simvastatin Tablets Recalled Nationwide Over Manufacturing Practice Deviations

Direct Rx is recalling 269 bottles of Simvastatin 40 mg nationwide due to Good Manufacturing Practice deviations. No adverse events have been reported. Consult your healthcare provider before changing your medication.

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 an FDA Class II recall involving manufacturing practice deviations with no reported illnesses or injuries. Per the severity rubric, voluntary precautionary recalls are classified as Moderate when no adverse events have been documented.

Plain-English summary

Direct Rx is recalling Simvastatin, USP, 40 mg tablets packaged in 90-count bottles (NDC 61919-0431-90). A total of 269 bottles were distributed nationwide throughout the United States.

The recall was initiated due to Good Manufacturing Practice (cGMP) deviations identified during the manufacturing process. This is a voluntary, firm-initiated recall.

The affected lot numbers and their expiration dates are: 28AP2212 (exp 7/31/2024), 24MA2230 (exp 7/31/2024), 11JA2203 (exp 3/31/2023), 02FE2217 (exp 2/28/2023), 10DE2126 (exp 2/28/2023), 25MA2201 (exp 5/31/2023), and 28FE2230 (exp 5/31/2023).

Patients currently taking this medication should consult their healthcare provider or pharmacist before making any changes to their medication. No adverse events have been reported in connection with this recall.

The recalled product

Product
Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Manufacturer
Direct Rx
Category
Drug — Statin
Hazard
Affected units
269

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)

  • Lot
  • expiry: 28AP2212
  • exp 7/31/2024
  • 24MA2230
  • 11JA2203
  • exp 3/31/2023
  • 02FE2217
  • exp 2/28/2023
  • 10DE2126
  • 25MA2201
  • exp 5/31/2023
  • 28FE2230
  • exp 5/31/2023.

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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