The Recall Desk
SevereFDA (Drugs)·D-0660-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls TM Drug Vials Due to Sterility Concerns

Partell Specialty Pharmacy is recalling specific lots of TM drug vials because they were sterilized using a non-approved method.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant risks such as lack of sterility assurance.

Plain-English summary

Partell Specialty Pharmacy is recalling specific lots of TM (ALP 50/PAPAV 30/PHENT1.5 mg) 3 mL amber vials. The recall was initiated because the firm used a non-approved method of sterilization for these drug products.

The affected products are prescription-only and were distributed only in Nevada. The specific lot numbers involved are 20180219@31 (best by 04/02/2018), 20180212@42, and 20180206@12 (best by 03/29/2018).

Consumers who have these specific products should stop using them and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
TM (ALP 50/PAPAV 30/PHENT1.5 mg), 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 (5)

  • Lot#: 20180219@31
  • BUD 04/02/2018
  • 20180212@42
  • 20180206@12
  • BUD 03/29/2018.

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 →