FDA Recalls Cerebrolysin Vials Due to Sterility Concerns
Advanced Nutriceuticals, LLC is recalling Cerebrolysin vials because production processes cannot assure sterility. The product was distributed to seven states.
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 and involves a lack of assurance of sterility for a medical product, which poses a significant risk of infection or serious injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Cerebrolysin, 107.5 mg/ml, 10 ml vials. The product was manufactured by Advanced Nutriceuticals, LLC and associated with The Guyer Institute of Molecular Medicine in Indianapolis, IN. The specific lot number is 1110202004, with an expiration date of 12/10/2020.
The recall was initiated due to a lack of assurance of sterility. The FDA cited concerns with production processes that cannot guarantee the sterility of products intended to be sterile. This is classified as an FDA Class II recall.
The affected product was distributed in California, Colorado, Florida, Indiana, Kentucky, Ohio, and Texas. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
- Manufacturer
- Advanced Nutriceuticals, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 1
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 (1)
- Lot #1110202004 Exp 12/10/2020
Distribution
Part of a larger recall action
This product is one of 17 recalled by Advanced Nutriceuticals, LLC 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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