Drug product

Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-127-05

D-1435-2012

April 09, 2012

Class II

Product summary

Firm: Dr. Reddy's Laboratories, Inc.
Event: Event 62591
Status: Terminated
Classification: Class II
Quantity: 1656 bottles
Official record key: drug-enforcement:D-1435-2012

Official wording

Reason: Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets

Code information: C201293 Exp Date 08/2013

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

Foreign Tablets
Labeling or packaging
reason.labeling_packaging · v1.0.0

mislabeled