PHENYLEPHRINE HYDROCHLORIDE Recall D-0401-2023
Description: Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-464-63, UPC 3 16729 46463 5; Carton NDC 16729-464-08, UPC 3 16729 46408 6
PHENYLEPHRINE HYDROCHLORIDE Recall D-0401-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0401-2023 |
| Event ID | 91657 |
| Brand | PHENYLEPHRINE HYDROCHLORIDE |
| Generic Name | PHENYLEPHRINE HYDROCHLORIDE |
| Manufacturer | PHENYLEPHRINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | PHENYLEPHRINE HYDROCHLORIDE |
| Drug Route | INTRAVENOUS |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 9,888 vials |
| Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 16729-464 16729-465 16729-466 |
| Drug UPC | 0316729464635 0316729466035 316729464635 |
| Recall Initiation Date | 20230207 |
| Report Date | 20230308 |
| Classification Date | 20230302 |
| Address | 1009 Slater Rd Ste 210B Durham, NC 27703-8446 United States |
| Recalling Firm | Accord Healthcare, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 04JA59TNSJ |
| Drug Application Number | ANDA213237 |
| Structured Product Labeling (SPL ID) | d9f34811-0e56-206b-e053-2a95a90af8a6 |
| Structured Product Labeling (SPL Set ID) | b9823fc0-95be-45d0-bdac-a36705f047bd |
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