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.
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 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
- 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
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
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