GM Manufacturing Recalls Therapeutic Care Dietary Supplements for cGMP Violations
GM Manufacturing is recalling Therapeutic Care A, B, and C dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) 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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source cites cGMP violations without reporting specific illnesses or injuries, fitting the Moderate severity criteria for regulatory non-compliance.
Plain-English summary
GM Manufacturing Inc. is recalling specific lots of Therapeutic Care A, B, and C dietary supplements. The affected products include 225cc HDPE bottles for formulations A and B, and capsules for formulation C. The recall involves 168,874 units distributed in California.
The recall was initiated due to significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements. The specific lots affected are LOTKZ1350, LOT KZ1351, and LOTKZ1352, all with an expiration date of 11/2016.
Consumers who have purchased these products should stop using them and contact GM Manufacturing Inc. for further instructions or a refund.
The recalled product
- Product
- Therapeutic Care A, B, C, 225cc HDPE Bottles for A,B. Capsules for C
- Manufacturer
- GM Manufacturing Inc.
- Category
- Food — Dietary Supplements
- Hazard
- Affected units
- 168,874
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 (4)
- LOTKZ1350
- EXP11/2016 LOT KZ1351
- EXP11/2016 LOTKZ1352
- EXP11/2016
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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