GM Manufacturing Recalls Calcium Formula Bottles for cGMP Violations
GM Manufacturing is recalling 501 bottles of Calcium Formula due to significant violations of dietary supplement manufacturing regulations.
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 and involves cGMP violations without reported illnesses, fitting the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
GM Manufacturing Inc. is recalling 501 units of Calcium Formula, 250 cc HDPE Bottles. The product has an expiration date of 08.2016 and was distributed in California.
The recall was initiated due to significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements. No specific illnesses or injuries have been reported in the source text.
Consumers who have this product should stop using it and contact GM Manufacturing Inc. for further instructions or a refund.
The recalled product
- Product
- Calcium Formula, 250 cc HDPE Bottles
- Manufacturer
- GM Manufacturing Inc.
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 501
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)
- EXP08.2016
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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