The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0655-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Methylcobalamin Injectable Liquid Due to Sterility Concerns

Partell Specialty Pharmacy is recalling Methylcobalamin 12.5 mg/mL Injectable Liquid in Nevada due to a non-approved method of sterilization.

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 involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug is a significant hazard that aligns with the upper end of Class II severity.

Plain-English summary

Partell Specialty Pharmacy is recalling Methylcobalamin 12.5 mg/mL, Injectable Liquid, packaged in 5 mL and 50 mL amber vials. The recall is limited to distribution in Nevada. The specific lot numbers and expiration dates are listed in the structured product information.

The recall was initiated because the firm used a non-approved method of sterilization for the drug products. This lack of assurance regarding sterility poses a potential risk to patients using the injectable medication.

Consumers and healthcare providers who have this product should stop using it and contact Partell Specialty Pharmacy at (702) 791-3800 for instructions on how to return or dispose of the medication.

The recalled product

Product
Methylcobalamin 12.5 mg/mL, Injectable Liquid, packaged in a) 5 mL amber vial, and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Manufacturer
Partell Specialty Pharmacy
Category
Drug — Injectable
Hazard

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 (16)

  • Lot#: a) 20180119@4
  • 20171016@10
  • 20171106@5
  • 20171214@55
  • 20180207@5 BUD 04/14/2018
  • 20180212@15
  • BUD 03/29/2018
  • 20180117@26
  • BUD 07/16/2018. b) 20180219@17
  • BUD 08/18/2018
  • 20180205@1
  • 20180102@39
  • 20180124@3
  • BUD 04/14/2018
  • 20180221@23
  • BUD 08/20/2018.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 49 recalled by Partell Specialty Pharmacy 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 49 products in this recall →

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