FDA Drug Recalls

Recalls / Class III

Class IIID-896-2013

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 76331-809-30)

Affected lot / code info
NDC 44118-809-30; Lot 40614B, exp. 9/14 and NDC 76331-809-30; lot 39736A, exp. 3/2014,

Why it was recalled

Subpotent; Beta carotene (Vitamin A)

Recalling firm

Firm
Stayma Consulting Service, LLC.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
5400 Laurel Springs Pkwy, Suite 803, Suwanee, Georgia 30024-6056

Distribution

Quantity
NDC 44118-809-30; 747 and NDC 76331-807-30; 1493
Distribution pattern
Nationwide.

Timeline

Recall initiated
2013-06-28
FDA classified
2013-08-16
Posted by FDA
2013-08-28
Terminated
2014-05-27
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-896-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.