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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Vitalab Pharmacy, Inc: Various Injectable Drugs Recalled for Potential Lack of Sterility

Agency Publication Date: August 21, 2018
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Summary

Vitalab Pharmacy, Inc. is recalling approximately 265 vials of several sterile injectable drug products, including Methylcobalamin, Alprostadil, and various Papaverine combinations. The recall was initiated because 3rd-party testing showed that the pharmacy's airflow patterns may not have been sufficient to ensure the drugs remained sterile during production. These products were distributed to patients across the United States between late 2017 and early 2018. Using an injectable drug that is not sterile can lead to serious or life-threatening infections.

Risk

The lack of proper airflow during the manufacturing process means these injectable medications may have been contaminated with bacteria or other microorganisms. Because these drugs are injected directly into the body, any contamination poses a significant risk of causing systemic infections or abscesses at the injection site.

What You Should Do

  1. Check your medication labels for the following product names and lot numbers: Methylcobalamin (Lots 02122018@77, 03092018@52, 02122018@76, 03142018@32, 01312018@40, 12282017@31, 01232018@17, 03052018@54, 03082018@39, 02082018@55, 02082018@56, 03062018@69, 02052018@56, 03122018@62, 02072018@95, 03122018@63, 02072018@96, 03122018@64, 02072018@97), Alprostadil (Lot 02122018@77), or various Papaverine/Phentolamine mixtures (Lots 03092018@52, 02122018@76, 03052018@54, 03062018@69, 02052018@56, 03122018@62, 02072018@95, 03122018@63, 02072018@96, 03122018@64, 02072018@97).
  2. Immediately stop using any affected injectable products and contact your healthcare provider if you have experienced any problems that may be related to using these drugs.
  3. Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and return any unused product to the pharmacy for a refund.
  4. Contact Vitalab Pharmacy, Inc. directly at 4045 E Bell Rd Ste 163, Phoenix, Arizona, 85032-2240 for further instructions regarding this recall.
  5. If you have additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall baseline remedy

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

Affected Products

Product: Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable
Model:
D-0728-2018
Lot Numbers:
02122018@77
03092018@52
02122018@76
03142018@32
01312018@40
12282017@31
01232018@17
03052018@54
03082018@39
02082018@55
02082018@56
03062018@69
02052018@56
03122018@62
02072018@95
03122018@63
02072018@96
03122018@64
02072018@97
Date Ranges: Exp 05/06/2018-09/10/2018
Product: Alprostadil 20 mcg/mL, Sterile injectable
Model:
D-0729-2018
Lot Numbers:
02122018@77 (Exp 05/13/2018)
Product: Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable
Model:
D-0730-2018
Lot Numbers:
03092018@52
02122018@76
Date Ranges: Exp 05/13/2018-06/07/2018
Product: Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable
Model:
D-0731-2018
Lot Numbers:
03052018@54 (Exp 06/03/2018)
Product: Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, sterile injectable
Model:
D-0732-2018
Lot Numbers:
03052018@54
Product: Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL, sterile injectables
Model:
D-0733-2018
Lot Numbers:
T101 03062018@69
02052018@56
T104 03122018@62
02072018@95
T105 03122018@63
02072018@96
T106 03122018@64
02072018@97
Date Ranges: Exp 06/04/2018-06/10/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80000
Status: Resolved
Manufacturer: Vitalab Pharmacy, Inc
Sold By: Vitalab Pharmacy, Inc
Manufactured In: United States
Units Affected: 5 products (178 vials; 2 vials; 22 vials; 3 vials; 60 vials)
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.

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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 ยท 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.