The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0650-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Progesterone Pellets Due to Sterility Concerns

Partell Specialty Pharmacy is recalling specific lots of Progesterone 50 mg pellets in Nevada because the products were sterilized using a non-approved method.

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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly when involving significant risks such as lack of sterility assurance in injectable or implantable drug products.

Plain-English summary

Partell Specialty Pharmacy is recalling specific lots of Progesterone 50 mg (SD) pellets in amber vials. The recall is being conducted because the firm used a non-approved method of sterilization for these drug products, which raises concerns about the assurance of sterility.

The affected products are prescription-only and were distributed only in Nevada. The recall covers five vials from specific lots with expiration dates ranging from April 2018 to August 2018. The lot numbers are 20171220@10, 20171017@83, 20171102@40, 20180118@97, and 00180213@32.

Consumers who have these specific products should stop using them and contact their healthcare provider or pharmacist for further instructions. 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
Progesterone 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 twist top surrounded by a wrapper,
Manufacturer
Partell Specialty Pharmacy
Category
Drug — Pharmaceutical
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 (10)

  • Lot#: 20171220@10
  • BUD 06/18/201
  • 20171017@83
  • BUD 04/15/2018
  • 20171102@40
  • BUD 05/01/2018
  • 20180118@97
  • BUD 07/17/2018
  • 00180213@32
  • BUD 08/12/2018.

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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