The Recall Desk
SevereFDA (Drugs)·D-1338-2019·Announced 2019-06-19

Pharm D Solutions Recalls Testosterone Cypionate Vials for Sterility Concerns

Pharm D Solutions is recalling specific lots of Testosterone Cypionate 200 mg/mL vials due to a lack of sterility assurance.

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, and the hazard involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Pharm D Solutions, LLC is recalling Testosterone Cypionate 200 mg/mL, a prescription-only medication available in 5 mL and 10 mL vials. The recall is being conducted because of a lack of sterility assurance in the product.

The affected product includes 114 vials of the 5 mL size and 566 vials of the 10 mL size. The specific lot numbers involved are 10242018:70/P and 10242018:70/A, both with an expiration date of 08/31/2019, and lot 02262019:49/A with an expiration date of 11/30/2019. The product was distributed nationwide within the United States.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the distributor or the recalling firm, Pharm D Solutions, LLC, at 1-844-263-6846.

The recalled product

Product
Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-10

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)

  • Lot #: a) 10242018:70/P
  • Exp. 08/31/2019
  • b) 10242018:70/A Exp. 08/31/2019
  • 02262019:49/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 →