The Recall Desk
ModerateFDA (Drugs)·D-894-2013·Announced 2013-08-28

Duet DHA Balanced Recalled for Subpotent Beta Carotene Content

Stayma Consulting Service is recalling Duet DHA Balanced tablets and softgels because the beta carotene (Vitamin A) content is subpotent.

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 III, which indicates a low probability of adverse health consequences. The hazard is a subpotent ingredient, which is a quality issue rather than a direct safety threat like contamination or injury.

Plain-English summary

Stayma Consulting Service, LLC. is recalling Duet DHA Balanced combination packs and physician samples. The affected products include 30-count tablet blister cards and 5-count softgel blister cards, as well as physician sample cartons containing envelopes with tablets and softgels. The recall covers specific lots with expiration dates in 2014.

The recall was initiated because the beta carotene (Vitamin A) content in the products is subpotent. This means the products do not contain the full amount of the active ingredient stated on the label. The products were distributed nationwide.

Consumers and healthcare providers should stop using the recalled products and return them to the point of purchase or contact the recalling firm for instructions.

The recalled product

Product
Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blister cards combination pack (NDC 44118-775-30 and NDC 44118-800-30) 2) physician samples (carton contain 7 envelopes each with one 5 count tablet blister card and 5 softgels (NDC 44118-800-05) Rx only, Ma

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 (8)

  • 1) NDC 44118-775-30
  • Lots 12120001
  • exp. 10/14 and 12120002
  • exp. 10/14
  • NDC 44118-800-30
  • exp 10/14 and 12080002
  • exp 8/14 2) Physician Samples: NDC 44118-800-05
  • Lot 12080001 exp. 8/14 and 12120002

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Stayma Consulting Service, 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 7 products in this recall →

Same manufacturer · Stayma Consulting Service, LLC.

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