Drug 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 76331-807-30)
D-895-2013
Product summary
- Event
- Event 65663
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,460 and 2,990
- Official record key
drug-enforcement:D-895-2013
Official wording
Reason: Subpotent; Beta carotene (Vitamin A)
Code information: 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 pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Subpotent