The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0771-2020·Announced 2020-01-22

Assurance Infusion Recalls Testosterone Cypionate Injections Due to Sterility Concerns

Assurance Infusion is recalling specific lots of Testosterone Cypionate 200mg/mL injections due to a lack of sterility assurance. The affected products were 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 FDA classified this as a Class II recall. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility assurance in an injectable drug warrants a 'Severe' rating (Score 4), as it poses a risk of serious infection or adverse health consequences.

Plain-English summary

Assurance Infusion is recalling seven vials of Testosterone Cypionate 200mg/mL Oil (Sesame) Injection. The recall is being conducted because of a lack of sterility assurance in the product. The affected lots are 08212019@17 with an expiration date of 02/17/2020, and 10232019@23 with an expiration date of 04/20/2020.

The recalled product was distributed nationwide within the United States. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected lots immediately and contact Assurance Infusion at (713) 533-8800 for further instructions or to arrange for a return or replacement.

The recalled product

Product
TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800
Manufacturer
Assurance Infusion
Category
Drug — Injectable Steroid
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 (2)

  • Lots: 08212019@17 Exp. 02/17/2020
  • 10232019@23 Exp. 04/20/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 118 recalled by Assurance Infusion 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 118 products in this recall →

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