Reported Mar 8, 2023 · Terminated
Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord…
Accord Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446
Is this the product you have?
Phenylephrine Hydrochloride InjectionUSP 10 mg/mL Rx Only1 mL Single Dose Vial
- Manufactured forAccord Healthcare, Inc., Durham
- NC 27703 Manufactured by
Intas Pharmaceuticals LimitedPharmezAhmedabad-382 213INDIAVial NDC 16729-464-63UPC 3 16729 46463 5Carton NDC 16729-464-08UPC 3 16729 46408 6
- Lot codes and dates
- Batches
R2101555R2101538R2101564Exp. Date 11/30/2023
- Batches
- Amount recalled
- 9,888 vials
This recall covers 67 products
The agency filed one notice per product. You are reading one of them; the other 66 are below.
54 more are in the archive.
Where it was sold
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Accord Healthcare, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.