FDA recall D-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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-07-11

Report date

2017-08-09

Termination date

2019-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1038-2017