Sun Pharmaceutical Recalls Atorvastatin Calcium Tablets Due to Foreign Matter
Sun Pharmaceutical Industries is recalling 1,416 bottles of Atorvastatin Calcium 40 mg tablets because a latex glove was found in one lot.
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: The recall involves a risk-of-harm product (foreign matter in medication) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 1,416 bottles of Atorvastatin Calcium Tablets, USP 40 mg, 500-count bottles. The recall affects Lot #AA33617 with an expiration date of 03/2021. The product is distributed nationwide in the U.S.A.
The recall was initiated because foreign matter, specifically a latex glove, was identified in one lot of the tablets. The product is a prescription-only medication manufactured by Sun Pharmaceutical Industries Limited in Mohali, India, and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, NJ.
Consumers who have this specific lot of Atorvastatin Calcium tablets should stop using them and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 1,416
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 (2)
- Lot#: AA33617
- Exp 03/2021
Distribution
Distributed nationwide across the United States.
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