The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0426-2017·Announced 2017-01-18

Testosterone Cypionate Injection Recalled for Incorrect Excipient Labeling

Pharm D Solutions is recalling Testosterone Cypionate 200 mg/mL vials because the label incorrectly lists grapeseed oil instead of sesame oil.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding the excipient description.

Plain-English summary

Pharm D Solutions, LLC is recalling Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials. The recall was initiated because the product description section of the label incorrectly states "in grapeseed oil" instead of "in sesame oil." The primary panel of the label is correct.

The affected product is prescription-only and intended for intramuscular injection. The specific lot involved is 09122016:34, with an expiration date of 09/07/2017. The recall covers 510 vials of the 4 mL size and 486 vials of the 5 mL size.

The product was distributed in Arizona and Washington. Consumers and healthcare providers should check their inventory for this specific lot number and stop using the product if it matches the description. They should contact Pharm D Solutions for further instructions or a refund.

The recalled product

Product
Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable Steroid
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 (2)

  • Lot: 09122016:34
  • exp 09/07/2017

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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