FDA-Drug2022-11-23Class II

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

Par Formulations Private Limited
Hazard

Failed Impurities/Degradation Specifications

Sold states
Nationwide within the United States
Affected count
218 bottles/100 capsules per bottle
Manufactured in
9/215 Pudupakkam-Vandalur Main Road, Pudupakkam, Kelambakkam, Chennai, N/A, India
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0061-2023

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