FDA-Drug2015-07-15Class II
Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
American Health Packaging
Hazard
CGMP Deviations: Firm did not adequately investigate customer complaints.
Sold states
Nationwide
Affected count
3,572 cartons
Manufactured in
2550 John Glenn Ave, Suite A, Columbus, OH, United States
Products
Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1224-2015Don't want to check this manually?
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