Recall: D-1038-2017

Class III - Minor Violations

Class IIIClassification

2017-07-11Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

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.

Reason

Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.