Graviti Pharmaceuticals Recalls Atorvastatin Calcium Tablets Due to Foreign Tablet Presence
Graviti Pharmaceuticals is recalling 29,056 bottles of 10 mg Atorvastatin Calcium Tablets because a 20 mg tablet was found in a bottle labeled for 10 mg tablets.
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: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, the product may cause temporary or medically reversible health consequences. The hazard is a potential dosing error due to a foreign tablet, which is a moderate risk.
Plain-English summary
Graviti Pharmaceuticals Private Limited is recalling 29,056 bottles of Atorvastatin Calcium Tablets, USP, 10 mg, 90-count. The recall is due to a customer complaint reporting the presence of a foreign 20 mg Atorvastatin Calcium Tablet in a bottle labeled as containing 10 mg tablets.
The affected product is identified by Lot # ATA318099C with an expiration date of 12/2020. The product was distributed nationwide in the USA. The tablets are manufactured for Biocon Pharma Inc. and manufactured by Graviti Pharmaceuticals Private Limited.
Consumers should check their medication for this specific lot number and expiration date. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.
- Manufacturer
- Graviti Pharmaceuticals Private Limited
- Category
- Drug — Prescription Medication
- Affected units
- 29,056
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 #: ATA318099C
- Exp 12/2020
Distribution
Distributed nationwide across the United States.
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