The Recall Desk
HighFDA (Drugs)·D-0744-2022·Announced 2022-04-13

Phenobarbital Sodium Injection recalled for manufacturing sterility defect

Vitae Enim Vitae Scientific, Inc. is recalling Phenobarbital Sodium Injection nationwide due to deviations from Current Good Manufacturing Practices (CGMP) that raise concerns about product sterility.

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: FDA Class II recall without reported illnesses or injuries, based on manufacturing deviations affecting sterility of an injectable drug. The hazard is theoretical rather than confirmed, meeting the High severity threshold for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Vitae Enim Vitae Scientific, Inc. is recalling Phenobarbital Sodium Injection, USP, 130 mg/mL. The recalled product consists of 18,531 boxes containing 25 x 1 mL vials (NDC 42494-416-25) and 4,492 boxes containing 3 x 1 mL vials (NDC 42494-416-03), manufactured for Cameron Pharmaceuticals, LLC. Multiple lots are affected with expiration dates ranging from March 2022 through August 2024.

The product is being recalled due to deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. Phenobarbital Sodium Injection is a prescription injectable medication, and lack of assurance of sterility poses a potential risk to patients.

The recalled product was distributed nationwide in the U.S.A. If you have received this product, do not use it. Contact your healthcare provider or pharmacy for guidance. Pharmacies and healthcare facilities should quarantine any affected stock and contact the manufacturer or distributor for return instructions.

The recalled product

Product
PHENOBARBITAL SODIUM (PHENOBARBITAL SODIUM)
Brand
PHENOBARBITAL SODIUM
Manufacturer
Vitae Enim Vitae Scientific, Inc.
Category
Drug — Injectable
Hazard

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) 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

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 →

Related recalls

Same brand · PHENOBARBITAL SODIUM

Same manufacturer · Vitae Enim Vitae Scientific, Inc.

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Same hazard · sterility defect

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