FDA Recalls Duet DHA 400 for Subpotent Beta Carotene
Stayma Consulting Service is recalling Duet DHA 400 multi-vitamin and Omega-3 products because they contain subpotent levels of beta carotene (Vitamin A).
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Duet DHA 400, a prescription-only product containing multi-vitamin tablets and Omega-3 softgel capsules. The recall is due to the presence of subpotent levels of beta carotene (Vitamin A) in the product.
The affected products were manufactured by Stayma Consulting Service, LLC. The recall covers specific lots of NDC 44118-807-30 (Lots 40614 and 40614A, exp. 9/14) and NDC 76331-807-30 (Lots 39736A, exp. 3/2014, and 41667, exp. 12/2014). The distribution pattern is listed as nationwide.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- Duet DHA 400, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-807-30) --- Also Manufactured for W.H. Nutritionals, Wilmington, DE (NDC…
- Manufacturer
- Stayma Consulting Service, LLC.
- Category
- Drug — Vitamins and Supplements
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 (6)
- NDC 44118-807-30 Lots 40614
- exp. 9/14 and 40614A
- exp. 9/14 NDC 76331-807-30 lot 39736A
- exp. 3/2014
- and lot 41667
- exp. 12/2014
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 →Related recalls
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