The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1336-2019·Announced 2019-06-19

Pharm D Solutions Recalls Testosterone Vials Due to Sterility Concerns

Pharm D Solutions is recalling 704 vials of Testosterone 200 mg/mL due to a lack of sterility assurance. The affected product 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.

Plain-English summary

Pharm D Solutions, LLC is recalling 704 vials of Testosterone 200 mg/mL, 30 mL vials, Rx only. The recall was initiated because of a lack of sterility assurance in the product. The affected product is identified by NDC 69699-1702-30.

The recall covers two specific lots: Lot # 10242018:70/B with an expiration date of 08/31/2019, and Lot # 10302018:63/A with an expiration date of 08/31/2019. The product was distributed nationwide within the United States.

Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions at 1-844-263-6846 for further instructions.

The recalled product

Product
Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-30
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable Steroid
Hazard
Affected units
704

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 #: 10242018:70/B Exp. 08/31/2019
  • 10302018:63/A Exp. 08/31/2019

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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