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D-0061-2023 Class II Terminated

Recalled by Par Formulations Private Limited — Chennai, N/A

FDA drug recall D-0061-2023 was initiated by Par Formulations Private Limited on November 10, 2022 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated August 18, 2023). Affected quantity: 218 bottles/100 capsules per bottle.

Recall Details

Product Type: Drugs
Report Date: November 23, 2022
Initiation Date: November 10, 2022
Termination Date: August 18, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 218 bottles/100 capsules per bottle

Product Description

Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 15429401, Exp. Date 08/2023