Drug product
Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blister cards combination pack (NDC 44118-775-30 and NDC 44118-800-30) 2) physician samples (carton contain 7 envelopes each with one 5 count tablet blister card and 5 softgels (NDC 44118-800-05) Rx only, Manufactured for Eckson Labs, Wilmington, DE
D-894-2013
Product summary
- Event
- Event 65663
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1) 12,278 and 28476; 2) 23740
- Official record key
drug-enforcement:D-894-2013
Official wording
Reason: Subpotent; Beta carotene (Vitamin A)
Code information: 1) NDC 44118-775-30, Lots 12120001, exp. 10/14 and 12120002, exp. 10/14; NDC 44118-800-30, Lots 12120001, exp 10/14 and 12080002, exp 8/14 2) Physician Samples: NDC 44118-800-05, Lot 12080001 exp. 8/14 and 12120002, exp. 10/14
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Subpotent