The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0645-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Injectable Solution Due to Sterility Concerns

Partell Specialty Pharmacy is recalling TM #1 Injectable solution because a non-approved sterilization method was used. The product was distributed only in Nevada.

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 in this case, a critical sterility failure in an injectable drug, align with the 'Severe' criteria (Score 4), as it poses a significant risk of harm.

Plain-English summary

Partell Specialty Pharmacy is recalling TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL amber vials. The recall is being conducted because the firm used a non-approved method of sterilization, which raises concerns about the sterility of the product.

The affected product is prescription-only and was distributed only in Nevada. The recall involves 15 vials from two specific lots: Lot 20180212@22 with a beyond-use date of 03/29/2018, and Lot 20180226@64 with a beyond-use date of 04/02/2018.

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
TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 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 Solution
Hazard
Affected units
15

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 (4)

  • Lot#: 20180212@22
  • BUD 03/29/2018
  • 20180226@64
  • BUD 04/02/2018.

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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