Ranbaxy Recalls Atorvastatin Calcium Tablets Due to Glass Particulates
Ranbaxy Inc. is recalling certain lots of Atorvastatin Calcium tablets because they may contain small glass particulates.
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 (glass particulates in oral medication) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Ranbaxy Inc. is recalling specific batches of Atorvastatin Calcium tablets, including 10 mg, 20 mg, and 40 mg strengths. The recall is due to the potential presence of small glass particulates in the tablets.
The affected product is manufactured for Ranbaxy Pharmaceuticals Inc. in Jacksonville, FL, by Ranbaxy Laboratories Ltd. in New Delhi, India. The recall covers 203,198 bottles of the 20 mg strength, distributed nationwide and in Puerto Rico. Specific lot numbers and expiration dates are listed in the official recall notice.
Consumers should check their medication for the affected lot numbers and expiration dates. If the product matches the recall criteria, they should stop using it and contact their healthcare provider or pharmacist for guidance on replacement medication.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Ranbaxy Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 203,198
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 (14)
- Lot #s: 2436731
- 2437381
- 2437940
- 2437942
- 2437945
- 2437947
- 2437952
- 2437953
- 2437960
- 2440676
- 2440677
- 2440680
- 2440681
- Exp 08/31/2014.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Ranbaxy 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 3 products in this recall →Related recalls
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