The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0522-2023·Announced 2023-04-12

Simvastatin Tablets Recalled Due to Manufacturing Compliance Deviations

Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 10 mg due to manufacturing compliance deviations identified at Accord Healthcare. No illnesses or injuries have been reported.

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 compliance deviations at the drug manufacturer. The hazard is manufacturing-related without specific health incidents reported; the score reflects risk-of-harm concern where injury has not yet been documented.

Plain-English summary

Simvastatin Tablets, USP, 10 mg in 90-count bottles (NDC 68788-9747-9) manufactured for Accord Healthcare, Inc., and distributed by Preferred Pharmaceuticals, Inc., are being recalled nationwide.

The recall was initiated following FDA inspection of Accord Healthcare's manufacturing facility, where current Good Manufacturing Practice (cGMP) deviations were identified. These manufacturing compliance deviations occurred at the facility responsible for producing this medication.

The recall affects 82 bottles with the following lot numbers and expiration dates: Lot C2222P, D1522L, E3122D, G2522J (expiration 9/30/2023) and Lot J1222R (expiration 10/31/2023). Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9
Manufacturer
Preferred Pharmaceuticals, Inc.
Category
Drug — Statin / Cholesterol Management
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 (7)

  • Lot: C2222P
  • D1522L
  • E3122D
  • G2522J
  • Exp 9/30/2023
  • Lot: J1222R
  • Exp 10/31/2023.

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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