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.
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: 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
- manufacturing-defect
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.
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