Drug 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
D-0061-2023
Product summary
- Event
- Event 91110
- Status
- Terminated
- Classification
- Class II
- Quantity
- 218 bottles/100 capsules per bottle
- Official record key
drug-enforcement:D-0061-2023
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: 15429401, Exp. Date 08/2023
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications