The Recall Desk
SevereFDA (Drugs)·D-0772-2020·Announced 2020-01-22

Assurance Infusion Recalls Testosterone Cypionate Injections Due to Sterility Concerns

Assurance Infusion is recalling 166 vials of Testosterone Cypionate 200mg/mL oil injection due to a lack of sterility assurance. The product was distributed nationwide.

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 agency classified this as an FDA Class II recall. According to the rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility assurance in an injectable drug) is classified as Severe.

Plain-English summary

Assurance Infusion is recalling 166 vials of Testosterone Cypionate 200mg/mL oil injection. The recall was initiated because of a lack of sterility assurance in the product.

The affected product is distributed nationwide within the United States. The recall covers specific lots with expiration dates ranging from March 10, 2020, to May 19, 2020.

Consumers and healthcare providers should stop using the recalled product and contact Assurance Infusion at (713) 533-8800 for further instructions.

The recalled product

Product
TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800
Manufacturer
Assurance Infusion
Category
Drug — Injectable Steroid
Hazard
Affected units
166

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 (12)

  • Lots: 09122019@9 Exp. 03/10/2020
  • 09242019@9 Exp. 03/22/2020
  • 09192019@20 Exp. 03/17/2020
  • 10032019@8 Exp. 03/31/2020
  • 10032019@11 Exp. 03/31/2020
  • 10182019@5 Exp. 04/15/2020
  • 10242019@7 Exp. 04/21/2020
  • 10232019@24 Exp. 04/20/2020
  • 11042019@12 Exp. 05/02/2020
  • 11212019@3 Exp. 05/19/2020
  • 11212019@2 Exp. 05/19/2020
  • 11042019@15 Exp. 05/02/2020

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 →

Related recalls

Same manufacturer · Assurance Infusion

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Same hazard · lack of sterility

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