Why it was recalled
Subpotent; Beta carotene (Vitamin A)
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-894-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 28, 2013
- FDA report date
- Aug 28, 2013
- Quantity
- 1) 12,278 and 28476; 2) 23740
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Stayma Consulting Service, LLC.
Original FDA data
Every field from FDA enforcement report D-894-2013, exactly as published.
Show all FDA fields
- City
- Suwanee
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 65663
- Address
- 5400 Laurel Springs Pkwy
- Address (line 2)
- Suite 803
- 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
- Postal code
- 30024-6056
- Report date
- Aug 28, 2013
- Product type
- Drugs
- Recall number
- D-894-2013
- Classification
- Class III
- Recalling firm
- Stayma Consulting Service, LLC.
- Product quantity
- 1) 12,278 and 28476; 2) 23740
- Termination date
- May 27, 2014
- Reason for recall
- Subpotent; Beta carotene (Vitamin A)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jun 28, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 16, 2013