Atorvastatin Calcium tablets recalled due to manufacturing practice deviations
Accord Healthcare is recalling Atorvastatin Calcium 20 mg tablets due to manufacturing practice deviations found during an FDA inspection. The affected products were distributed in the United States, Puerto Rico, and Canada.
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: This is a FDA Class II recall for manufacturing practice deviations without reported illnesses or adverse events. The quality control risk to a prescription medication is substantial but remains theoretical in the absence of confirmed harm.
Plain-English summary
Accord Healthcare, Inc. is recalling approximately 241,585 bottles of Atorvastatin Calcium Tablets USP 20 mg in two package sizes (90-tablet and 1,000-tablet bottles). The medication was manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India for Accord Healthcare, Inc., based in Durham, North Carolina.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered during an FDA inspection.
The affected products were distributed throughout the United States, including Puerto Rico and Canada. Multiple manufacturing batches are included in the recall, with expiration dates ranging from February 2023 to June 2024. Consumers taking this medication should contact their healthcare provider or pharmacist regarding this recall and should not discontinue use without consulting a healthcare professional.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug
- Hazard
- Affected units
- 241,585
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)R2100305
- Exp. Date 2/28/2023
- R2200227
- Exp. Date 1/31/2024
- R2200797
- Exp. Date 6/30/2024
- b) R2101423
- R2101438
- R2101447
- R2101446
- Exp. Date 10/31/2023
- R2200040
- R2200041
- R2200052
- R2200043
- R2200044
- R2200051
- R2200060
- R2200061
- R2200062
UPCs (2)
- 316729045155
- 316729045179
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 67 recalled by Accord Healthcare, 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 67 products in this recall →Related recalls
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