The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0641-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Methionine, Inositol, and Choline Vials

Partell Specialty Pharmacy is recalling 11 vials of Methionine/Inositol/Choline in Nevada due to a non-approved sterilization 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Partell Specialty Pharmacy is recalling 11 vials of Methionine 15mg/Inositol 50mg/Choline 100mg. The product is packaged in 5mL and 50 mL amber vials and is prescription-only. The recall is limited to distribution in Nevada.

The recall was initiated because the firm used a non-approved method of sterilization, resulting in a lack of assurance of sterility. The affected lots include Lot # 20180129@18 with a beyond-use date of 4/14/2018, and Lots # 20171127@6, 20180207@12, and 20180108@16 with a beyond-use date of 04/14/2018.

Consumers and healthcare providers should stop using the affected product and contact Partell Specialty Pharmacy at (702) 791-3800 or their healthcare provider for further instructions.

The recalled product

Product
Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL 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
Affected units
11

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 (5)

  • a) Lot #: 20180129@18
  • BUD 4/14/2018 b) Lot #: 20171127@6
  • 20180207@12
  • 20180108@16
  • BUD 04/14/2018.

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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