The Recall Desk
HighFDA (Drugs)·D-0525-2023·Announced 2023-04-12

Simvastatin Tablets Recalled Due to Manufacturing Practice Deviations

Preferred Pharmaceuticals is recalling Simvastatin 40 mg tablets nationwide due to manufacturing practice violations at the production facility. The recall is precautionary.

What this means for you

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 an FDA Class II recall involving a prescription medication with current Good Manufacturing Practice (cGMP) deviations identified during inspection of the manufacturing facility. No illnesses or injuries have been reported. The recall is precautionary, addressing process control violations rather than confirmed product contamination or demonstrated harm.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Simvastatin Tablets, USP, 40 mg, across multiple package sizes (30-count, 60-count, and 90-count bottles), distributed nationwide. The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations identified at Accord Healthcare, the manufacturing facility, during a regulatory inspection.

The affected products include multiple lot numbers with expiration dates ranging from March 2023 through February 2025.

Consumers who have received this product should contact their pharmacy or healthcare provider to determine if they have an affected lot. Do not discontinue use of prescribed medication without consulting a healthcare professional. Consumers can reference the NDC numbers and lot codes provided in the official FDA recall notice to identify their product.

The recalled product

Product
Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
Manufacturer
Preferred Pharmaceuticals, Inc.
Category
Drug
Hazard
  • cgmp-deviation

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 (18)

  • a) Lot: B0922G
  • Exp. Date: 5/31/2023
  • F0322G
  • Exp. Date: 7/25/2024
  • H2622M
  • Exp. Date: 8/31/2024
  • J1422B
  • K0722G
  • Exp. Date: 10/31/2024
  • L1922A
  • Exp. Date: 2/28/2025
  • b) Lot: F2922S
  • Exp. Date: 8/31/2023
  • H0322G Exp. Date: 7/31/2023
  • c) Lot: A1322I
  • Exp. Date: 3/31/2023
  • H1122C
  • Exp. Date: 8/31/2024.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category