GM Manufacturing Recalls Serrapeptase Bottles for cGMP Violations
GM Manufacturing is recalling Serrapeptase, 100cc HDPE Bottles due to significant violations of current Good Manufacturing Practice (cGMP) regulations for dietary supplements.
The agency’s classification
FDA (Food): 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is related to manufacturing compliance rather than a specific acute pathogen or physical defect.
Plain-English summary
GM Manufacturing is voluntarily recalling Serrapeptase, 100cc HDPE Bottles. The recall is being conducted because the product was found to have significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.
The affected product consists of 801 units of Serrapeptase, 100cc HDPE Bottles. The specific lot number is LOTKZ1320, and the expiration date is February 2016. The product was distributed in California.
Consumers who have purchased this product should stop using it and contact GM Manufacturing for further instructions or a refund.
The recalled product
- Product
- Serrapeptase, 100cc HDPE Bottles
- Manufacturer
- GM Manufacturing Inc.
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 801
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)
- LOTKZ1320 EXPFEB2016
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 46 recalled by GM Manufacturing Inc. under a single FDA (Food) 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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