FDA Recalls Rosuvastatin Tablets Due to Manufacturing Practice Deviations
Accord Healthcare is recalling Rosuvastatin 20 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations. The deviations could affect product quality and safety.
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 classified this as Class II, indicating potential for serious adverse health consequences from manufacturing practice deviations. No illnesses or injuries are mentioned in the source, limiting the score to 3 per the rubric.
Plain-English summary
Accord Healthcare is recalling Rosuvastatin 20 mg tablets (NDC 16729-286-15 and 16729-286-17) distributed throughout the United States, Puerto Rico, and Canada. The recall affects 43,302 bottles and was initiated following an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations.
CGMP deviations relate to how medications are manufactured and can affect product quality and safety. Patients currently taking Rosuvastatin should consult their healthcare provider for guidance on whether to discontinue the medication.
Consumers with unused bottles should return them to their pharmacy or follow medication disposal instructions provided by their pharmacist. Healthcare providers may contact Accord Healthcare, Inc. for information about replacement product availability.
The recalled product
- Product
- ROSUVASTATIN (ROSUVASTATIN)
- Brand
- ROSUVASTATIN
- Manufacturer
- Accord Healthcare, 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 (20)
- Batches: a) P2006560
- Exp. Date 11/30/2023
- P2101562
- Exp. Date 2/28/2024
- b) P2006561
- P2006562
- P2006587
- P2100035
- P2006600
- P2006603
- P2006604
- P2006605
- P2006606
- P2100542
- Exp. Date 12/31/2023
- P2100543
- P2100544
- P2100545
- P2101485
- P2101484
UPCs (2)
- 316729286152
- 316729286176
Distribution
Distribution scope not specified by the agency.
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