FDA Drug Recalls

Recalls / Class II

Class IID-180-2013

Product

Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-344-30

Affected lot / code info
Lot #: C108376, C108634, Exp 11/13

Why it was recalled

Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.

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
48, 754 bottles (C108376)/47,520 bottles (C108634)
Distribution pattern
Nationwide

Timeline

Recall initiated
2012-08-01
FDA classified
2013-02-28
Posted by FDA
2013-03-06
Terminated
2013-05-24
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-180-2013. 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