The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0523-2023·Announced 2023-04-12

Simvastatin Tablets, USP, 80 mg Recalled Due to Manufacturing Deviations

Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 80 mg due to manufacturing quality control deviations identified at Accord Healthcare during FDA inspection. Approximately 57 bottles distributed nationwide.

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: FDA Class II recall involving manufacturing quality control deviations. Per the rubric, this constitutes a risk-of-harm product, but no illnesses or injuries have been reported. When the hazard is theoretical and no harm is reported, the maximum score is 3 (High).

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Simvastatin Tablets, USP, 80 mg (90-count bottles) to the consumer level due to current Good Manufacturing Practice (cGMP) deviations identified at the manufacturing facility operated by Accord Healthcare, Inc. during an FDA inspection.

The affected product lots are: B0222S with expiration date 2/29/2024, and F1121B and G2721L with expiration date 11/30/2023. Approximately 57 bottles of this prescription medication were distributed nationwide.

Consumers with questions regarding this recall should contact their pharmacy or healthcare provider.

The recalled product

Product
Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9
Manufacturer
Preferred Pharmaceuticals, Inc.
Category
Drug
Hazard
Affected units
57

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 (5)

  • Lot: B0222S
  • Exp 2/29/2024
  • Lot: F1121B
  • G2721L
  • Exp 11/30/2023.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Preferred Pharmaceuticals, 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 17 products in this recall →

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