Pravastatin Sodium Tablets recall: Impurity Out of Spec
Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA.
Why was Pravastatin Sodium Tablets recalled?
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
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 #: a) C700220, Exp 06/18; b) C700220, Exp 06/18
- Product
- Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA.
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Quantity
- 544 bottles
- Distribution
- Nationwide in the USA
- Recall date
- August 9, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)