The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0659-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls TM #6 Due to Sterility Concerns

Partell Specialty Pharmacy is recalling TM #6 drug products 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are classified as Severe (Score 4), as they are not Class I but involve significant risk.

Plain-English summary

Partell Specialty Pharmacy is recalling TM #6 (ALP 25/PAPAV/PHENT1), 3 mL amber vials, due to a lack of assurance of sterility. The recall is being conducted because the firm used a non-approved method of sterilization for these drug products.

The affected products are prescription-only and were distributed in Nevada. Specific lot numbers and expiration dates are listed in the recall documentation, including lots 20180206@7, 20180212@41, and 20180219@40.

Consumers who have this product should contact their healthcare provider or pharmacist for guidance on how to proceed. 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.

The recalled product

Product
TM #6 (ALP 25/PAPAV/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@7
  • BUD 03/23/2018
  • 20180212@41
  • BUD 03/29/2018
  • 20180219@40
  • 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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