The Recall Desk
SevereFDA (Drugs)·D-0644-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

Partell Specialty Pharmacy is recalling 7 vials of Testosterone Cypionate 200mg/mL in Nevada because the firm used a non-approved method of sterilization.

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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug represents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for serious adverse health consequences.

Plain-English summary

Partell Specialty Pharmacy is recalling 7 vials of Testosterone Cypionate 200mg/mL, 5 mL amber vials, prescription only. The recall is due to a lack of assurance of sterility, as the firm used a non-approved method of sterilization for these drug products.

The affected products were distributed only in Nevada. The specific lot numbers and best-by dates involved in the recall are: 20180130@2 (BUD 7/29/2018), 20180109@1 (BUD 07/08/2018), 20180212@51 (BUD 08/11/2018), 20171212@4 (BUD 06/10/2018), 20180123@6 (BUD 07/22/2018), 20171204@4 (BUD 06/02/2018), and 20171228@15 (BUD 03/28/2018).

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

The recalled product

Product
Testosterone Cypionate 200mg/mL, 5 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 Steroids
Hazard
Affected units
7

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 (14)

  • Lot #: 20180130@2
  • BUD 7/29/2018
  • 20180109@1
  • BUD 07/08/2018
  • 20180212@51
  • BUD 08/11/2018
  • 20171212@4
  • BUD 06/10/2018
  • 20180123@6
  • BUD 07/22/2018
  • 20171204@4
  • BUD 06/02/2018
  • 20171228@15
  • BUD 03/28/2018.

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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Same hazard · sterility

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