The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0661-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls TM #3 Drug Vials Due to Sterility Concerns

Partell Specialty Pharmacy is recalling TM #3 drug vials because they were sterilized using a non-approved method, raising concerns about sterility assurance.

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, and the rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or in this context, a critical sterility failure in a drug product, aligns with a Severe rating (Score 4) due to the potential for serious health consequences from non-sterile injectable drugs.

Plain-English summary

Partell Specialty Pharmacy is recalling TM #3 (ALP10/PAPAV12/PHENT1), 3 mL amber vials, prescription only. The recall was initiated because the firm used a non-approved method of sterilization for these drug products, which creates a lack of assurance regarding sterility.

The affected products are distributed in Nevada only. Specific lots involved in the recall include 20180206@3 (Best Use Date 03/23/2018), 20180212@15 (Best Use Date 03/29/2018), and 20180219@16 (Best Use Date 04/02/2018).

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

The recalled product

Product
TM #3 (ALP10/PAPAV12/PHENT1), 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
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 (6)

  • Lot#: 20180206@3
  • BUD 03/23/2018
  • 20180212@15
  • BUD 03/29/2018
  • 20180219@16
  • 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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