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.
Recall notice
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.
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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
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 number | Product, codes & lots | Quantity |
|---|---|---|
| D-0728-2018 | Methylcobalamin 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 05/06/2018-09/10/2018 | 178 vials |
| D-0729-2018 | Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc; Lot #: 02122018@77, Exp 05/13/2018 | 2 vials |
| D-0730-2018 | Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc; Lot #: 03092018@52, 02122018@76, Exp 05/13/2018-06/07/2018 | 22 vials |
| D-0731-2018 | Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc; Lot #: 03052018@54, Exp 06/03/2018 | 3 vials |
| D-0732-2018 | Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.; Lot #: 03052018@54 | N/A |
| D-0733-2018 | Papaverine 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 06/04/2018-06/10/2018 | 60 vials |
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.
