The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0674-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Estradiol Pellets Due to Sterility Concerns

Partell Specialty Pharmacy is recalling Estradiol 12.5 mg pellets in Nevada due to a non-approved sterilization 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility, which poses a significant risk of infection or serious injury.

Plain-English summary

Partell Specialty Pharmacy is recalling Estradiol 12.5 mg (SD) pellets in amber vials. The recall is due to a lack of assurance of sterility resulting from the use of a non-approved method of sterilization.

The affected product is prescription-only and was distributed only in Nevada. Specific lots include 20180219@88, 20180208@19, and 20180219@45, with a best-use date of August 18, 2018.

Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Estradiol 12.5 mg (SD) pellets in 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 — Prescription Medication
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 (4)

  • a) Lot#: 20180219@88
  • 20180208@19
  • 20180219@45
  • BUD 08/18/2018.

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