FDA Drug recall D-0403-2023
Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham,…
- FDA Drug
- Class II
- terminated
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham,… by Accord Healthcare, citing CGMP Deviations: recalling drug products following an FDA inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0403-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-02-07 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Accord Healthcare |
| Distribution | PR |
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.
Identifiers
| upc | 316729466035 |
|---|---|
| code_info | Batches: R2101591, R2101590, R2101599, Exp. Date 11/30/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Accord Healthcare
- Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare - Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare - Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 167…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare - Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 1…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare - Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2761…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0403-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.