FDA-Drug2014-08-13Class III
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.
Wockhardt Usa Inc.
Hazard
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Sold states
Nationwide
Affected count
840 bottles
Manufactured in
20 Waterview Blvd., Suite 3, N/A, Parsippany, NJ, United States
Products
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1513-2014Don't want to check this manually?
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