Drug & medication recalls

Sun Pharmaceutical Industries, Inc. recalls buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical I…

Recall date
June 27, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1446-2016
FDA classification
Class III
Brand / firm
Sun Pharmaceutical Industries, Inc.
Sold / distributed
Nationwide

Why it was recalled

Failed Dissolution Specifications

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86

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