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Drug recall · FDA · Published April 24, 2018

Vitalab Pharmacy, Inc recalls Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc

Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.

🇺🇸 FDA recall #D-0728-2018DrugVitalab Pharmacy, Inc ›
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Recalling firmVitalab Pharmacy, Inc4045 E Bell Rd Ste 163, N/A · Phoenix, AZ 85032-2240
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
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Source Page by GovInfoNow · govinfonow.com/recall/40590-vitalab-pharmacy-inc-recalls-methylcobalamin-for-injection-1mg-ml-and · Recall date April 24, 2018 · FDA enforcement record: FDA #D-0728-2018

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“Vitalab Pharmacy, Inc recalls Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc.” GovInfoNow, recall dated April 24, 2018. https://govinfonow.com/recall/40590-vitalab-pharmacy-inc-recalls-methylcobalamin-for-injection-1mg-ml-and. Based on FDA recall #D-0728-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0728-2018%22&limit=1).

How to tell if you have this one

  • Brand
    Vitalab Pharmacy, Inc
  • Category
    Drug
FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    The recalled product was distributed to patients throughout the United States.
Recall numberProduct, codes & lotsQuantity
D-0728-2018Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc; Lot #: 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; Exp 05/06/2018-09/10/2018178 vials
D-0729-2018Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc; Lot #: 02122018@77, Exp 05/13/20182 vials
D-0730-2018Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc; Lot #: 03092018@52, 02122018@76, Exp 05/13/2018-06/07/201822 vials
D-0731-2018Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc; Lot #: 03052018@54, Exp 06/03/20183 vials
D-0732-2018Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.; Lot #: 03052018@54N/A
D-0733-2018Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL, sterile injectables, Vitalab Pharmacy, Inc; Lot #:T101 03062018@69, 02052018@56, T104 03122018@62, 02072018@95, T105 03122018@63, 02072018@96, T106 03122018@64, 02072018@97, Exp 06/04/2018-06/10/201860 vials
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Contact Vitalab Pharmacy, Inc

We’ve drafted a message you can send Vitalab Pharmacy, Inc to request your refund or repair — edit it as you like.

Subject: Recall D-0728-2018 — Vitalab Pharmacy, Inc Vitalab Pharmacy, Inc recalls Methylcobalamin for injection, 1mg/mL and 10 mg

Hello,

I own a Vitalab Pharmacy, Inc recalls Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc that is covered by recall D-0728-2018 from Vitalab Pharmacy, Inc.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0728-2018 (April 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0728-2018 to see it in context.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA