Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Subpotent; Beta carotene (Vitamin A)
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 76331-809-30)
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Reason Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed…
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed…
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.