Par Formulations Private Limited: Drug Recall

Recall #D-0061-2023 · 11/10/2022

Class II: Risk

Recall Details

Recall Number
D-0061-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Par Formulations Private Limited
Status
Terminated
Date Initiated
11/10/2022
Location
Chennai, N/A, India
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
218 bottles/100 capsules per bottle

Reason for Recall

Failed Impurities/Degradation Specifications

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

Distribution Pattern

Nationwide within the United States

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.