The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1337-2019·Announced 2019-06-19

Pharm D Solutions Recalls Testosterone Cyp/Pro Vials for Sterility Concerns

Pharm D Solutions is recalling 371 vials of Testosterone Cyp/Pro 95/5% due to a lack of sterility assurance. The affected prescription medication was distributed nationwide.

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 agency classified this as an FDA Class II recall. According to the rubric, FDA Class II recalls involving significant risks such as sterility issues in injectable medications are categorized as Severe.

Plain-English summary

Pharm D Solutions, LLC is recalling 371 vials of Testosterone Cyp/Pro 95/5%, 10 mL vials, which are prescription-only medication. The recall was initiated because of a lack of sterility assurance in the product.

The affected product was distributed nationwide within the United States. The recall covers specific lots with expiration dates of August 16, 2019, and November 30, 2019.

Consumers who have this product should stop using it and contact Pharm D Solutions at 1-844-263-6846 for further instructions.

The recalled product

Product
Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable Steroid
Hazard
Affected units
371

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 (2)

  • Lot #: 01312019:02 Exp. 08/16/2019
  • 02072019:45/A Exp. 11/30/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 recalled by Pharm D Solutions, LLC 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 18 products in this recall →

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