Agency classClass IIOur severity:High FDA (Drugs)·D-0743-2022·Announced 2022-04-13

Phenobarbital Sodium Injection Recalled for Sterility Assurance Deviations

Vitae Enim Vitae Scientific is recalling Phenobarbital Sodium Injection nationally due to deviations from manufacturing practices that compromise sterility assurance on this injectable drug.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug with questioned sterility due to CGMP deviations. No illnesses or injuries have been reported. Per the rubric, lack of sterility in an injectable product represents a risk-of-harm situation where injury has not yet been reported, scoring 3 (High).

Plain-English summary

Phenobarbital Sodium Injection USP 65mg/mL is being recalled by Vitae Enim Vitae Scientific, Inc., manufactured for Cameron Pharmaceuticals, LLC. The recall affects approximately 26,347 boxes distributed nationwide in the United States.

The recall was initiated due to deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of these injectable products. Phenobarbital sodium is a prescription medication administered by intramuscular injection.

The recall includes multiple lot numbers across two packaging configurations (25x1mL vials and 3x1mL vials per box), with expiration dates ranging from March 2022 through August 2024.

Healthcare providers and patients who have this product should stop using it and contact their pharmaceutical suppliers for replacement stock. For guidance on ongoing treatment needs, consult with a healthcare provider.

The recalled product

Product: PHENOBARBITAL SODIUM (PHENOBARBITAL SODIUM)
Brand: PHENOBARBITAL SODIUM
Manufacturer: Vitae Enim Vitae Scientific, Inc.
Category: Drug — Injectable
Hazard: lack-of-sterility
microbial-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot #: a) 20VPSI007
Exp 3/31/2022
20VPSI015
Exp 5/30/2022
20VPSI018
Exp 6/1/2022
20VPSI032
Exp 11/30/2022
21VPSI002
21VPSI003
Exp 1/31/2023
21VPSI006
Exp 3/31/2023
21VPSI012
21VPSI020
Exp 5/31/2023
21VPSI035
Exp 7/31/2023
21VPSI037
21VPSI038

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Vitae Enim Vitae Scientific, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same brand · PHENOBARBITAL SODIUM

High
Phenobarbital Sodium Injection recalled for manufacturing sterility defect
FDA (Drugs) · 2022-04-13

Same manufacturer · Vitae Enim Vitae Scientific, Inc.

See all →

High
Tetracaine Injection Recalled for Sterility Assurance Manufacturing Defect
FDA (Drugs) · 2022-04-13
High
Drug recall: Papaverine hydrochloride injection due to sterility concerns
FDA (Drugs) · 2022-04-13

Same hazard · lack of sterility