Reported Aug 9, 2017 · Terminated
Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles…
Dr. Reddy's Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- 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 byDr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA
- Distributed byDr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
- Lot codes and dates
Lot #: a) C700220Exp 06/18b) C700220Exp 06/18
- Amount recalled
- 544 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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