Stayma Recalls Duet DHA 400 ec Due to Subpotent Beta Carotene
Stayma Consulting Service is recalling specific lots of Duet DHA 400 ec because the beta carotene (Vitamin A) content is subpotent.
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
Stayma Consulting Service, LLC. is recalling specific lots of Duet DHA 400 ec, a prescription-only product containing multi-vitamin tablets and Omega-3 softgel capsules. The recall is due to the product being subpotent, specifically regarding the beta carotene (Vitamin A) content.
The affected products are distributed nationwide. The specific lots involved are NDC 44118-809-30 (Lot 40614B, exp. 9/14) and NDC 76331-809-30 (Lot 39736A, exp. 3/2014). The product is manufactured for Eckson Labs and W.H. Nutritionals in Wilmington, DE.
Consumers with these specific products should stop using them and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Duet DHA 400 ec, 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 44118-809-30) and Manufactured for W.H. Nutritionals, Wilmington, DE (NDC…
- Manufacturer
- Stayma Consulting Service, LLC.
- Category
- Drug — Supplement
- Hazard
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 (5)
- NDC 44118-809-30
- Lot 40614B
- exp. 9/14 and NDC 76331-809-30
- lot 39736A
- exp. 3/2014
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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