Assurance Infusion Recalls CJC-1295 and Ipamorelin Injections Due to Sterility Concerns
Assurance Infusion is recalling 19 vials of CJC-1295 and Ipamorelin injections nationwide due to a lack of sterility assurance.
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 severity score under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in injectable drugs.
Plain-English summary
Assurance Infusion is recalling 19 vials of CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Injection in 2 mL vials. The recall is being conducted because of a lack of sterility assurance for the product.
The affected product was distributed nationwide within the United States. The recall includes specific lots with expiration dates ranging from January 2020 to February 2020.
Consumers who have this product should stop using it and contact Assurance Infusion at (713) 533-8800 for further instructions.
The recalled product
- Product
- CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable
- Hazard
- Affected units
- 19
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 (3)
- Lots: 08212019@29 Exp. 02/17/2020
- 07152019@12 Exp. 01/11/2020
- 07082019@26 Exp. 01/04/2020
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.
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