The Recall Desk
SevereFDA (Drugs)·D-0639-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls HCG Vials Due to Sterility Concerns

Partell Specialty Pharmacy is recalling HCG 1000 units/mL vials in Nevada because a non-approved sterilization method was used.

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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving potential health risks.

Plain-English summary

Partell Specialty Pharmacy is recalling four vials of HCG 1000 units/mL, packaged in 2 mL and 6 mL amber vials, due to a lack of assurance of sterility. The recall is limited to products distributed in Nevada.

The firm is conducting this recall because a non-approved method of sterilization was used for these drug products. The specific lots affected include 20180219@6, 20180207@14, 0180214@22, and 20180220@7, with expiration dates ranging from March 24, 2018, to April 6, 2018.

Consumers who have these specific vials should stop using them and contact Partell Specialty Pharmacy at (702) 791-3800 for further instructions.

The recalled product

Product
HCG 1000 units/mL, packaged in a) 2 mL and b) 6 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 (8)

  • a) Lot#: 20180219@6
  • BUD 04/05/2018
  • b) 20180207@14
  • BUD 03/24/2018
  • 0180214@22
  • BUD 03/31/2018
  • 20180220@7
  • BUD 04/06/2018.

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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