The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0642-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Methionine Injection Due to Sterility Concerns

Partell Specialty Pharmacy is recalling Methionine 25mg/Inositol 50mg/Choline 50mg/B12 1mg injections because they were sterilized using a non-approved method.

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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe.

Plain-English summary

Partell Specialty Pharmacy is recalling specific lots of Methionine 25mg/Inositol 50mg/Choline 50mg/B12 1mg, packaged in 5 mL and 50 mL amber vials. The recall is due to the use of a non-approved method of sterilization, which raises concerns about the sterility of the drug products.

The affected products are prescription-only and were distributed in Nevada. Specific lot numbers and expiration dates are listed in the recall notice. 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.

Patients who have received these injections should contact their healthcare provider for guidance. The recalling firm is responsible for managing the recall and notifying affected parties.

The recalled product

Product
Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL amber vial and b) 50mL 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 (8)

  • a) Lot #: 20180123@9
  • 20171222@11
  • BUD 4/14/2018
  • 20180214@7
  • BUD 08/14/2018. b) Lot #: 20180221@3
  • BUD 08/21/2018
  • 20180214@6
  • BUD 08/14/2018.

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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