Recalls / Class III
Class IIID-894-2013
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
- Affected lot / code info
- 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
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
- 1) 12,278 and 28476; 2) 23740
- 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-894-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.