FDA recall D-0061-2023

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-11-10

Report date

2022-11-23

Termination date

2023-08-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chennai, N/A, India

Primary source

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