The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0408-2023·Announced 2023-03-08

Prescription Drug Simvastatin Recalled for Manufacturing Deviations

Accord Healthcare is recalling Simvastatin 5 mg tablets distributed in the United States, Puerto Rico, and Canada. The recall follows an FDA inspection that identified manufacturing practice deviations.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall involving manufacturing practice deviations identified during an FDA inspection. No illnesses or injuries are reported in the source, but the manufacturing quality issue represents potential risk to patient safety, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Accord Healthcare, Inc. is recalling Simvastatin Tablets USP 5 mg in 90-count bottles (NDC 16729-156-15) and 1,000-count bottles (NDC 16729-156-17) distributed in the United States, Puerto Rico, and Canada. The recall affects approximately 256,648 bottles across multiple batch numbers with expiration dates ranging from June 2023 to May 2025.

The recall was initiated following an FDA inspection that identified deviations from current good manufacturing practice (CGMP) standards. The tablets were manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India, for Accord Healthcare, Inc. in Durham, North Carolina.

Patients taking the affected Simvastatin tablets should contact their pharmacy or healthcare provider for guidance on whether their medication may be affected. Pharmacists and healthcare providers should identify and quarantine any affected product and arrange for its return or destruction.

The recalled product

Product
SIMVASTATIN (SIMVASTATIN)
Brand
SIMVASTATIN
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
Affected units
256,648

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)

  • Batches: a) R2100818
  • Exp. Date 6/30/2023
  • R2100964
  • R2100824
  • R2100820
  • R2100822
  • R2101201
  • Exp. Date 9/30/2023
  • R2101198
  • R2101199
  • R2101200
  • R2101355
  • Exp. Date 10/31/2023
  • R2200035
  • R2200515
  • Exp. Date 4/30/2025
  • R2200514
  • R2200516
  • b) R2200310
  • Exp Date 9/30/2023

UPCs (2)

  • 316729156158
  • 316729156172

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, Inc. 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 67 products in this recall →

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