Recall archive / FDA drug enforcement
Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Hea... — FDA record D-0403-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 7, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; NDC 16729-466-03, UPC 3 16729 46603 5
- Reason
- CGMP Deviations: recalling drug products following an FDA inspection.
- Classification
- Class II
- Recalling firm
- Accord Healthcare, Inc.
- Quantity
- 37,691 vials
- Agency-reported status
- Terminated
- Source record identifier
- D-0403-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Batches: R2101591, R2101590, R2101599, Exp. Date 11/30/2023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
United States including Puerto Rico and Canada
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Mar 8, 2023
- Recall initiation date
- Feb 7, 2023
- Center classification date
- Mar 2, 2023
- Termination date
- Apr 22, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.