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
FDA recall notice · announced November 23, 2022 · Par Formulations Private Limited
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
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
Notes
Distribution: Nationwide within the United States
Lot/code information: Lot #: 15429401, Exp. Date 08/2023
Quantity: 218 bottles/100 capsules per bottle
Status: Terminated
Products in this recall event:
- 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, (D-0061-2023)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.