Assurance Infusion Recalls BPC-157 Vials Due to Sterility Concerns
Assurance Infusion is recalling BPC-157 vials nationwide because the product lacks sterility assurance.
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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the text, the lack of sterility assurance in an injectable product represents a significant health risk consistent with the Severe classification for Class II recalls.
Plain-English summary
Assurance Infusion is recalling 28 vials of BPC-157 2000 mcg/mL in 5 mL vials. The recall is being conducted because the product lacks sterility assurance.
The affected lots are 11132019@15 (Exp. 02/11/2020), 12112019@25 (Exp. 02/13/2020), and 11202019@9 (Exp. 02/13/2020). The product was distributed nationwide within the United States.
Consumers should stop using the product and contact Assurance Infusion at (713) 533-8800 for further instructions.
The recalled product
- Product
- BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable
- Hazard
- Affected units
- 28
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: 11132019@15 Exp. 02/11/2020
- 12112019@25 Exp. 02/13/2020
- 11202019@9 Exp. 02/13/2020
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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