Simvastatin Tablets Recalled Due to Manufacturing Process Deviations
Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 20 mg, in three package sizes due to manufacturing process deviations at Accord Healthcare. The affected tablets were distributed nationwide.
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: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is manufacturing process deviations without a specific identified defect or confirmed harm, making it a precautionary recall rather than a severe or critical event.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling Simvastatin Tablets, USP, 20 mg across three package sizes (30-count, 60-count, and 90-count bottles) due to manufacturing process deviations identified during a U.S. Food and Drug Administration inspection of Accord Healthcare, Inc.
The recalled tablets were distributed nationwide. Specific lot numbers and expiration dates are provided in the official FDA recall notice.
Consumers who have affected medication should contact their healthcare provider or pharmacy. Lot numbers can be checked against the official FDA recall information to determine if a specific product is affected.
The recalled product
- Product
- Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug
- Hazard
- manufacturing-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 (20)
- a) Lot: A0923R
- Exp. Date: 2/28/2025
- A1222K
- B1822C
- Exp. Date: 5/31/2024
- C3022D
- F2322V
- Exp. Date: 6/30/2024
- H1522H
- Exp. Date: 8/31/2024
- I1621O
- Exp. Date: 1/31/2024
- I2222G
- J1822R
- Exp. Date: 9/30/2024
- L1621N
- b) Lot: F0822Q
- I0122J
- L0821C
- c) Lot: I1521P
Distribution
Distributed nationwide across the United States.
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