The Recall Desk
ModerateFDA (Food)·F-2269-2014·Announced 2014-08-06

GM Manufacturing Recalls Actra-SX Vinyl Bags for cGMP Violations

GM Manufacturing is recalling 188 units of Actra-SX Vinyl Bags distributed in California due to significant violations of dietary supplement cGMP regulations.

What this means for you

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 significant cGMP violations, but the source text does not report any illnesses, injuries, or specific high-risk pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

GM Manufacturing Inc. is voluntarily recalling 188 units of Actra-SX Vinyl Bags. The product was distributed in California (CA) and carries a code of 11/1/13.

The recall was initiated because the dietary supplements were found to have significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements. The source text does not specify the exact nature of the manufacturing violations or report any illnesses or injuries associated with the product.

Consumers who possess these products should stop using them and contact GM Manufacturing Inc. for further instructions or a refund, as per standard recall procedures.

The recalled product

Product
Actra-SX, Vinyl Bags
Affected units
188

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)

  • 11/1/13

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.

See all 46 products in this recall →