The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0728-2018·Announced 2018-05-16

Vitalab Methylcobalamin Injection Recalled Due to Sterility Concerns

Vitalab Pharmacy is recalling 178 vials of Methylcobalamin for injection because airflow patterns may not support aseptic production, raising sterility concerns.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectables) are categorized as Severe.

Plain-English summary

Vitalab Pharmacy, Inc. is recalling 178 vials of Methylcobalamin for injection, 1mg/mL and 10 mg/mL, sterile injectable. The recall is due to a lack of assurance of sterility. Upon review of recent third-party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.

The recalled product was distributed to patients throughout the United States. The affected lots include 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, and 02072018@97. The expiration dates for these products range from 05/06/2018 to 09/10/2018.

Patients who have received these products should contact their healthcare provider for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
Manufacturer
Vitalab Pharmacy, Inc
Category
Drug — Injectable
Hazard
Affected units
178

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

  • 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

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 6 recalled by Vitalab Pharmacy, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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