CLASS II Drug recall · Reported 13 Apr 2022 · FDA Enforcement Report

Phenobarbital Sodium Injection, USP, 130 mg/mL recalled

Vitae Enim Vitae Scientific is recalling Phenobarbital Sodium Injection, USP, 130 mg/mL, packaged as a) mL Vials per box (, distributed nationwide in the US. The recall was initiated on 14 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 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.

NDC42494-415, 42494-416

Quantity recalleda) 18,531 boxes; b) 4,492 boxes

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0744-2022
FDA event ID: 89803
Recalling firm: Vitae Enim Vitae Scientific, San Diego, CA
Brand: Phenobarbital Sodium
Manufacturer: Cameron Pharmaceuticals
Classification: Class II
Status: Terminated
Recall initiated: 14 Mar 2022
FDA classified: 5 Apr 2022
Reported: 13 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

14 Mar 2022	Recall initiated by company
5 Apr 2022	Classified by FDA	+22 days
13 Apr 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Nationwide in the U.S.A

Nationwide

Questions about this recall

Why was it 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.

Which lots are affected?

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.

Where was it sold?

Nationwide in the U.S.A

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 89803

This product is part of a recall event; the main page for the event is Tetracaine 1% Tetracaine HCI Injection, USP, 20mg recalled.

Reported	Class	Recall	Company	Reason	Where
13 Apr 2022	CLASS II	Tetracaine 1% Tetracaine HCI Injection, USP, 20mg recalled	Vitae Enim Vitae Scientific	Sterility	Nationwide
13 Apr 2022	CLASS II	Phenobarbital Sodium Injection, USP, 65mg/mL recalledPhenobarbital Sodium	Vitae Enim Vitae Scientific	Sterility	Nationwide
13 Apr 2022	CLASS II	Papaverine Hydrochloride Injection, USP, 60 mg/ (30 mg/mL) recalledPapaverine Hydrochloride	Vitae Enim Vitae Scientific	Sterility	Nationwide

More recalls from Vitae Enim Vitae Scientific

All 4

Reported	Class	Recall	Company	Reason	Where
13 Apr 2022Drug	CLASS II	Papaverine Hydrochloride Injection, USP, 60 mg/ (30 mg/mL) recalledPapaverine Hydrochloride	Vitae Enim Vitae Scientific	Sterility	Nationwide
13 Apr 2022Drug	CLASS II	Phenobarbital Sodium Injection, USP, 65mg/mL recalledPhenobarbital Sodium	Vitae Enim Vitae Scientific	Sterility	Nationwide
13 Apr 2022Drug	CLASS II	Tetracaine 1% Tetracaine HCI Injection, USP, 20mg recalled	Vitae Enim Vitae Scientific	Sterility	Nationwide

Other Phenobarbital recalls

All 18

Reported	Class	Recall	Company	Reason	Where
25 May 2022Drug	CLASS III	Phenobarbital Elixir, USP 20 mg/, 1 Pint recalled by Monarch PCM	Monarch PCM	Other	TN
13 Apr 2022Drug	CLASS II	Phenobarbital Sodium Injection, USP, 65mg/mL recalledPhenobarbital Sodium	Vitae Enim Vitae Scientific	Sterility	Nationwide
2 Jun 2021Drug	CLASS II	Phenobarbital Tablets, USP 32.4 mg recalled by Cardinal Health	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
19 Jun 2019Drug	CLASS II	Phenobarbital Oral Solution, USP, 20 mg recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
17 Apr 2019Drug	CLASS II	Phenobarbital Oral Solution, USP 20 mg/, unit dose cup recalled by Lohxa	Lohxa	Other	MA, NY, WY