Recalls / Class III
Class IIID-1038-2017
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.
- Brand name
- Pravastatin Sodium
- Generic name
- Pravastatin Sodium
- Active ingredient
- Pravastatin Sodium
- Route
- Oral
- NDCs
- 55111-229, 55111-230, 55111-231, 55111-274
- FDA application
- ANDA076714
- Affected lot / code info
- Lot #: a) C700220, Exp 06/18; b) C700220, Exp 06/18
Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 544 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-07-11
- FDA classified
- 2017-07-31
- Posted by FDA
- 2017-08-09
- Terminated
- 2019-04-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1038-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.