The Recall Desk
HighFDA (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.

What this means for you

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.

Related recalls

Same brand · PHENOBARBITAL SODIUM

Same category