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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