FDA Drug Recalls

Recalls / Class II

Class IID-1435-2012

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

Affected lot / code info
C201293 Exp Date 08/2013

Why it was recalled

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

Recalling firm

Firm
Dr. Reddy's Laboratories, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
200 Somerset Corporate Blvd Fl 7th, N/A, Bridgewater, New Jersey 08807-2862

Distribution

Quantity
1656 bottles
Distribution pattern
Nationwide and Puerto Rico

Timeline

Recall initiated
2012-04-09
FDA classified
2012-07-31
Posted by FDA
2012-08-08
Terminated
2013-01-24
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1435-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls