Medications & Supplements/Prescription Drugs

Injectable Tetracaine, Papaverine, and Phenobarbital Recalled for Sterility

Agency Publication Date: April 5, 2022

Summary

Vitae Enim Vitae Scientific, Inc. is recalling 42,852 units of several injectable medications, including Tetracaine HCl, Papaverine Hydrochloride, and Phenobarbital Sodium. These prescription medications were manufactured for Cameron Pharmaceuticals and Oryza Pharmaceuticals and distributed nationwide. The recall was issued because manufacturing issues at the facility call into question whether the products are truly sterile. While no injuries or infections have been reported to date, any product intended for injection must be sterile to ensure patient safety.

Risk

Injectable medications that are not sterile can cause serious or life-threatening infections because they are introduced directly into the body. Contaminated injections can lead to localized infections or systemic conditions like sepsis.

What You Should Do

This recall affects injectable Tetracaine HCl (1%), Papaverine Hydrochloride (30 mg/mL), and Phenobarbital Sodium (65 mg/mL and 130 mg/mL) sold in single-use vials and packaged in boxes of various quantities.
To identify affected products, check the NDC codes and lot numbers on the vial or carton. Affected NDC codes include 42494-437-10, 72516-024-25, 72516-024-10, 42494-415-25, 42494-415-03, 42494-416-25, and 42494-416-03. See the Affected Products section below for the full list of affected codes.
Stop using the recalled injectable medications immediately. Medical facilities and wholesalers should quarantine any remaining stock.
Contact Vitae Enim Vitae Scientific, Inc. or your medication distributor to arrange for the return of any affected products.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL)

Variants: 10 x 2ml Single Use Vials per box

Lot Numbers:

21VTHI017 (Exp 5/31/2023)

21VTHI018 (Exp 5/31/2023)

21VTHI019 (Exp 5/31/2023)

NDC:

42494-437-10

Manufactured for Cameron Pharmaceuticals, LLC.

Product: PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL)

Variants: 25 x 2mL Single Use Vials per box, 10 x 2mL Single Use Vials per box

Lot Numbers:

20VPHI037 (Exp 12/31/2022)

20VPHI038 (Exp 12/31/2022)

20VPHI039 (Exp 12/31/2022)

21VPHI021 (Exp 6/30/2023)

21VPHI022 (Exp 6/30/2023)

21VPHI023 (Exp 6/30/2023)

21VPHI047 (Exp 10/31/2023)

21VPHI048 (Exp 10/31/2023)

NDC:

72516-024-25

72516-024-10

Manufactured for Oryza Pharmaceuticals, Inc.

Product: PHENOBARBITAL Sodium Injection, USP, 65mg/mL

Variants: 25 x 1 mL Vials per box, 3 x 1 mL Vials per box

Lot Numbers:

20VPSI007 (Exp 3/31/2022)

20VPSI015 (Exp 5/30/2022)

20VPSI018 (Exp 6/1/2022)

20VPSI032 (Exp 11/30/2022)

21VPSI002 (Exp 1/31/2023)

21VPSI003 (Exp 1/31/2023)

21VPSI006 (Exp 3/31/2023)

21VPSI012 (Exp 5/31/2023)

21VPSI020 (Exp 5/31/2023)

21VPSI035 (Exp 7/31/2023)

21VPSI037 (Exp 8/31/2023)

21VPSI038 (Exp 8/31/2023)

21VPSI043 (Exp 10/31/2023)

21VPSI044 (Exp 10/31/2023)

21VPSI050 (Exp 11/30/2023)

21VPSI051 (Exp 11/30/2023)

22VPSI004 (Exp 7/31/2024)

22VPSI006 (Exp 8/31/2024)

20VPSI008 (Exp 3/31/2022)

20VPSI019 (Exp 6/30/2022)

NDC:

42494-415-25

42494-415-03

Manufactured for Cameron Pharmaceuticals, LLC.

Product: PHENOBARBITAL Sodium Injection, USP, 130 mg/mL

Variants: 25 x 1 mL Vials per box, 3 x 1 mL Vials per box

Lot Numbers:

20VPSI011 (Exp 4/30/2022)

20VPSI014 (Exp 5/31/2022)

20VPSI020 (Exp 7/31/2022)

20VPSI022 (Exp 7/31/2022)

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)

20VPSI009 (Exp 3/31/2022)

NDC:

42494-416-25

42494-416-03

Manufactured for Cameron Pharmaceuticals, LLC.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89803

Status: Resolved

Manufacturer: Vitae Enim Vitae Scientific, Inc.

Sold By: Cameron Pharmaceuticals, LLC.; Oryza Pharmaceuticals, Inc.

Manufactured In: United States

Units Affected: 4 products (722 boxes; a) 2,098 boxes; b) 700 boxes; a) 21,501 boxes; b) 4,846 boxes; a) 18,531 boxes; b) 4,492 boxes)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects injectable Tetracaine HCl (1%), Papaverine Hydrochloride (30 mg/mL), and Phenobarbital Sodium (65 mg/mL and 130 mg/mL) sold in single-use vials and packaged in boxes of various quantities.

To identify affected products, check the NDC codes and lot numbers on the vial or carton. Affected NDC codes include 42494-437-10, 72516-024-25, 72516-024-10, 42494-415-25, 42494-415-03, 42494-416-25, and 42494-416-03. See the Affected Products section below for the full list of affected codes.

Stop using the recalled injectable medications immediately. Medical facilities and wholesalers should quarantine any remaining stock.

Contact Vitae Enim Vitae Scientific, Inc. or your medication distributor to arrange for the return of any affected products.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Affected Products

Product: TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL)

Variants: 10 x 2ml Single Use Vials per box

Lot Numbers:

21VTHI017 (Exp 5/31/2023)

21VTHI018 (Exp 5/31/2023)

21VTHI019 (Exp 5/31/2023)

NDC:

42494-437-10

Manufactured for Cameron Pharmaceuticals, LLC.

Product: PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL)

Variants: 25 x 2mL Single Use Vials per box, 10 x 2mL Single Use Vials per box

Lot Numbers:

20VPHI037 (Exp 12/31/2022)

20VPHI038 (Exp 12/31/2022)

20VPHI039 (Exp 12/31/2022)

21VPHI021 (Exp 6/30/2023)

21VPHI022 (Exp 6/30/2023)

21VPHI023 (Exp 6/30/2023)

21VPHI047 (Exp 10/31/2023)

21VPHI048 (Exp 10/31/2023)

NDC:

72516-024-25

72516-024-10

Manufactured for Oryza Pharmaceuticals, Inc.

Product: PHENOBARBITAL Sodium Injection, USP, 65mg/mL

Variants: 25 x 1 mL Vials per box, 3 x 1 mL Vials per box

Lot Numbers:

20VPSI007 (Exp 3/31/2022)

20VPSI015 (Exp 5/30/2022)

20VPSI018 (Exp 6/1/2022)

20VPSI032 (Exp 11/30/2022)

21VPSI002 (Exp 1/31/2023)

21VPSI003 (Exp 1/31/2023)

21VPSI006 (Exp 3/31/2023)

21VPSI012 (Exp 5/31/2023)

21VPSI020 (Exp 5/31/2023)

21VPSI035 (Exp 7/31/2023)

21VPSI037 (Exp 8/31/2023)

21VPSI038 (Exp 8/31/2023)

21VPSI043 (Exp 10/31/2023)

21VPSI044 (Exp 10/31/2023)

21VPSI050 (Exp 11/30/2023)

21VPSI051 (Exp 11/30/2023)

22VPSI004 (Exp 7/31/2024)

22VPSI006 (Exp 8/31/2024)

20VPSI008 (Exp 3/31/2022)

20VPSI019 (Exp 6/30/2022)

NDC:

42494-415-25

42494-415-03

Manufactured for Cameron Pharmaceuticals, LLC.

Product: PHENOBARBITAL Sodium Injection, USP, 130 mg/mL

Variants: 25 x 1 mL Vials per box, 3 x 1 mL Vials per box

Lot Numbers:

20VPSI011 (Exp 4/30/2022)

20VPSI014 (Exp 5/31/2022)

20VPSI020 (Exp 7/31/2022)

20VPSI022 (Exp 7/31/2022)

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)

20VPSI009 (Exp 3/31/2022)

NDC:

42494-416-25

42494-416-03

Manufactured for Cameron Pharmaceuticals, LLC.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89803

Status: Resolved

Manufacturer: Vitae Enim Vitae Scientific, Inc.

Sold By: Cameron Pharmaceuticals, LLC.; Oryza Pharmaceuticals, Inc.

Manufactured In: United States

Units Affected: 4 products (722 boxes; a) 2,098 boxes; b) 700 boxes; a) 21,501 boxes; b) 4,846 boxes; a) 18,531 boxes; b) 4,492 boxes)

Distributed To: Nationwide