Reported Apr 13, 2022 · Terminated

PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x…

Vitae Enim Vitae Scientific, 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: Vitae Enim Vitae Scientific, Inc. · 3030 Bunker Hill St Ste 203 · San Diego, CA · 92109-5754

Is this the product you have?

PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (NDC 42494-416-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.

Lot codes and dates: Lot # a) 20VPSI011
Exp. 4/30/2022
20VPSI014
Exp. 5/31/2022
20VPSI020
20VPSI022
20VPSI023
Exp. 7/31/2022
21VPSI007
Exp. 3/31/2023
21VPSI013
Exp. 5/31/2023
21VPSI027
Exp. 6/30/2023
21VPSI039
Exp. 8/31/2023
21VPSI042
Exp. 10/31/2023
21VPSI049
Exp. 11/30/2023
21VPSI052
Exp. 12/31/2023
22VPSI005
Exp. 7/31/2024
22VPSI007
Exp. 8/31/2024
Lots
b) 22VPSI007
Exp. 8/31/2024
20VPSI009
Exp. 3/31/2022
20VPSI020
Exp. 7/31/2022
21VPSI039
Exp. 8/31/2023
22VPSI005
Exp. 7/31/2024
Amount recalled: a) 18,531 boxes; b) 4,492 boxes

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Nationwide

Why it was recalled

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

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 Vitae Enim Vitae Scientific, 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.

By hazard

All recall categories · Browse the whole archive