The Recall Desk
SevereFDA (Drugs)·D-1098-2020·Announced 2020-04-15

Innovative Compounding Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

Innovative Compounding Pharmacy is recalling Testosterone Cypionate In Sesame Oil 200mg/ml injectable vials because the firm cannot assure the sterility of the product.

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, which corresponds to a Severe rating under the rubric for significant injury or property damage reports, or high-risk contamination.

Plain-English summary

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy is recalling Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only. The recall is being conducted because the firm lacks assurance of the sterility of the product.

The affected product was distributed to patients in California, Maine, and Texas. The recall covers five specific lots: Lot # 11152019@41 (expires after 04-07-2020), Lot # 12042019@12 (expires after 04-26-2020), Lot # 12172019@9 (expires after 05-09-2020), Lot # 01032020@49 (expires after 05-26-2020), and Lot # 01162020@55 (expires after 06-08-2020).

Patients who have received this product should contact their healthcare provider for instructions on how to dispose of the medication and to obtain a replacement if necessary.

The recalled product

Product
Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Manufacturer
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
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 (10)

  • Lot #: 11152019@41
  • Expires after 04-07-2020
  • Lot # 12042019@12
  • Expires after 04-26-2020
  • Lot # 12172019@9
  • Expires after 05-09-2020
  • Lot # 01032020@49
  • Expires after 05-26-2020
  • Lot # 01162020@55
  • Expires after 06-08-2020

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 5 recalled by Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy 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 5 products in this recall →

Related recalls

Same manufacturer · Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

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Same hazard · sterility

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