Status
Terminated
Drug Enforcement D-0061-2023
Failed Impurities/Degradation Specifications
Classification
Class II
Report Date
November 23, 2022
Termination Date
August 18, 2023
Product Information
- 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
- Product quantity
- 218 bottles/100 capsules per bottle
- Reason for recall
- Failed Impurities/Degradation Specifications
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Par Formulations Private Limited
- Address
-
9/215 Pudupakkam-Vandalur Main Road, Pudupakkam, Kelambakkam
India - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0061-2023
- Event ID
- 91110
- Recall initiation date
- November 10, 2022
- Center classification date
- November 15, 2022
- Code info
- Lot #: 15429401, Exp. Date 08/2023
- More code info
- —