Atorvastatin Calcium Tablets 40 mg recall: Impurity Out of Spec
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05
Why was Atorvastatin Calcium Tablets 40 mg recalled?
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number: T600279, 6/2018
- Product
- Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Quantity
- 12,579 bottles
- Distribution
- Nationwide
- Recall date
- February 7, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)