The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0658-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls TM #4 Due to Sterility Concerns

Partell Specialty Pharmacy is recalling TM #4 drug products because a non-approved method of sterilization was used.

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 source text identifies the recall as FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving significant risks such as lack of assurance of sterility.

Plain-English summary

Partell Specialty Pharmacy is recalling TM #4 (ALP 20/PAPAV/PHENT 2), 3 mL amber vials, prescription only. The recall is being conducted because the firm used a non-approved method of sterilization for these drug products.

The affected products are distributed in Nevada. Specific lot numbers include 20180219@27 and 20180212@18, with a best-use date of 04/02/2018. The FDA has classified this recall as Class II.

Consumers who have this product should contact their healthcare provider or the recalling firm for instructions on how to proceed.

The recalled product

Product
TM #4 (ALP 20/PAPAV/PHENT 2), 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 — Pharmacy Compounded
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 (3)

  • Lot#: 20180219@27
  • 20180212@18
  • 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 →

Related recalls

Same manufacturer · Partell Specialty Pharmacy

See all →

Same hazard · sterility

See all →

Similar recalls