Medications & Supplements/Prescription Drugs

La Vita Compounding Pharmacy, LLC: Sterile Injectable Drugs Recalled Due to Lack of Processing Controls

Agency Publication Date: July 13, 2018

Summary

La Vita Compounding Pharmacy, LLC is recalling various sterile injectable drug products, including Methylcobalamin, Methyl Folate CA+, and Glutathione, totaling approximately 36,841 units dispensed. These products were produced under conditions that call into question their sterility, which could lead to serious infections in patients. These prescription-only medications were distributed to patients in California and are packaged in 10 mL and 30 mL vials.

Risk

The lack of adequate processing controls during manufacturing means the products may not be completely sterile. If a non-sterile drug is injected into a patient, it can cause severe, life-threatening infections or other serious health complications.

What You Should Do

Locate your medication vials and check the label for 'la VITA Compounding Pharmacy' and your specific lot number and expiration date.
For Methylcobalamin 1mg/mL Injection, check for lot numbers 139140@3 (Exp 07/23/2018), 141106@1 (Exp 08/21/2018), 142919@13 (Exp 09/17/2018), 143291@6 (Exp 09/23/2018), 145701@3 (Exp 10/29/2018), and 146932@3 (Exp 11/19/2018).
For Methyl Folate CA+ 1mg/ml Injection, check for lot numbers 140089@1 (Exp 08/06/2018), 141968@6 (Exp 09/03/2018), 143381@2 (Exp 09/24/2018), 145265@13 (Exp 10/22/2018), and 146479@6 (Exp 11/12/2018).
For Glutathione 200mg/mL Injection, check for lot numbers 144326@3 (Exp 07/10/2018) and 145953@2 (Exp 08/05/2018).
Immediately stop using any affected medication and contact your healthcare provider or pharmacist for guidance regarding alternative treatments.
Return any unused product to the pharmacy for a refund and contact La Vita Compounding Pharmacy at 858-453-2500 for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 if you have additional questions or wish to report an adverse event.

Your Remedy Options

Full Refund

Return for refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water)

Model:

D-0921-2018

Lot Numbers:

139140@3 (Exp 07/23/2018)

141106@1 (Exp 08/21/2018)

142919@13 (Exp 09/17/2018)

143291@6 (Exp 09/23/2018)

145701@3 (Exp 10/29/2018)

146932@3 (Exp 11/19/2018)

Date Ranges: 07/23/2018, 08/21/2018, 09/17/2018, 09/23/2018, 10/29/2018, 11/19/2018

Product: Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water)

Model:

D-0922-2018

Lot Numbers:

140089@1 (Exp 08/06/2018)

141968@6 (Exp 09/03/2018)

143381@2 (Exp 09/24/2018)

145265@13 (Exp 10/22/2018)

146479@6 (Exp 11/12/2018)

Date Ranges: 08/06/2018, 09/03/2018, 09/24/2018, 10/22/2018, 11/12/2018

Product: Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water)

Model:

D-0923-2018

Lot Numbers:

144326@3 (Exp 07/10/2018)

145953@2 (Exp 08/05/2018)

Date Ranges: 07/10/2018, 08/05/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80416

Status: Resolved

Manufacturer: La Vita Compounding Pharmacy, LLC

Sold By: Patient specific prescription only

Manufactured In: United States

Units Affected: 3 products (19,040 mL total dispensed in 10 mL and 30 mL vials; 17,610 mL total dispensed in 10 mL and 30 mL vials; 191 vials)

Distributed To: California

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

Locate your medication vials and check the label for 'la VITA Compounding Pharmacy' and your specific lot number and expiration date.

For Methylcobalamin 1mg/mL Injection, check for lot numbers 139140@3 (Exp 07/23/2018), 141106@1 (Exp 08/21/2018), 142919@13 (Exp 09/17/2018), 143291@6 (Exp 09/23/2018), 145701@3 (Exp 10/29/2018), and 146932@3 (Exp 11/19/2018).

For Methyl Folate CA+ 1mg/ml Injection, check for lot numbers 140089@1 (Exp 08/06/2018), 141968@6 (Exp 09/03/2018), 143381@2 (Exp 09/24/2018), 145265@13 (Exp 10/22/2018), and 146479@6 (Exp 11/12/2018).

For Glutathione 200mg/mL Injection, check for lot numbers 144326@3 (Exp 07/10/2018) and 145953@2 (Exp 08/05/2018).

Immediately stop using any affected medication and contact your healthcare provider or pharmacist for guidance regarding alternative treatments.

Return any unused product to the pharmacy for a refund and contact La Vita Compounding Pharmacy at 858-453-2500 for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 if you have additional questions or wish to report an adverse event.

Affected Products

Product: Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water)

Model:

D-0921-2018

Lot Numbers:

139140@3 (Exp 07/23/2018)

141106@1 (Exp 08/21/2018)

142919@13 (Exp 09/17/2018)

143291@6 (Exp 09/23/2018)

145701@3 (Exp 10/29/2018)

146932@3 (Exp 11/19/2018)

Date Ranges: 07/23/2018, 08/21/2018, 09/17/2018, 09/23/2018, 10/29/2018, 11/19/2018

Product: Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water)

Model:

D-0922-2018

Lot Numbers:

140089@1 (Exp 08/06/2018)

141968@6 (Exp 09/03/2018)

143381@2 (Exp 09/24/2018)

145265@13 (Exp 10/22/2018)

146479@6 (Exp 11/12/2018)

Date Ranges: 08/06/2018, 09/03/2018, 09/24/2018, 10/22/2018, 11/12/2018

Product: Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water)

Model:

D-0923-2018

Lot Numbers:

144326@3 (Exp 07/10/2018)

145953@2 (Exp 08/05/2018)

Date Ranges: 07/10/2018, 08/05/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80416

Status: Resolved

Manufacturer: La Vita Compounding Pharmacy, LLC

Sold By: Patient specific prescription only

Manufactured In: United States

Units Affected: 3 products (19,040 mL total dispensed in 10 mL and 30 mL vials; 17,610 mL total dispensed in 10 mL and 30 mL vials; 191 vials)

Distributed To: California