PHENOXYBENZAMINE HYDROCHLORIDE Recall D-0061-2023
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
PHENOXYBENZAMINE HYDROCHLORIDE Recall D-0061-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0061-2023 |
| Event ID | 91110 |
| Brand | PHENOXYBENZAMINE HYDROCHLORIDE |
| Generic Name | PHENOXYBENZAMINE HYDROCHLORIDE |
| Manufacturer | PHENOXYBENZAMINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | PHENOXYBENZAMINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide within the United States |
| Quantity | 218 bottles/100 capsules per bottle |
| Recall Reason | Failed Impurities/Degradation Specifications |
| Drug Classification | Class II |
| Drug Code Info | 20221123 |
| Product NDC | 49884-038 |
| Drug UPC | 0349884038014 |
| Recall Initiation Date | 20221110 |
| Report Date | 20221123 |
| Classification Date | 20221115 |
| Address | 9/215 Pudupakkam-Vandalur Main RoadPudupakkam, Kelambakkam Chennai, India |
| Recalling Firm | Par Formulations Private Limited |
| Initial Notification | Letter |
| Unique Ingredient Identifier | X1IEG24OHL |
| Drug Application Number | ANDA204522 |
| Structured Product Labeling (SPL ID) | 18957b76-0baa-495e-8917-03b6fc16d065 |
| Structured Product Labeling (SPL Set ID) | 037202a5-e08b-4f9d-9df8-a6dd25027748 |
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