The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0139-2021·Announced 2020-12-23

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.

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 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
Hazard
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

Distributed in 7 states:

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.

See all 17 products in this recall →

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