CLASS III Drug recall · Reported 28 Aug 2013 · FDA Enforcement Report
Duet DHA Balanced tablet blister cards recalled
Stayma Consulting Service is recalling Duet DHA Balanced tablet blister cards and softgels blister cards combination pack (, distributed nationwide in the US. The recall was initiated on 28 Jun 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-894-2013
- FDA event ID
- 65663
- Recalling firm
- Stayma Consulting Service, Suwanee, GA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Jun 2013
- FDA classified
- 16 Aug 2013
- Reported
- 28 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 28 Jun 2013 | Recall initiated by company | |
| 16 Aug 2013 | Classified by FDA | +49 days |
| 28 Aug 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent; Beta carotene (Vitamin A)
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Subpotent; Beta carotene (Vitamin A)
Which lots are affected?
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 was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 65663This product is part of a recall event; the main page for the event is Nata Komplete, containing one bottle of multi-vitamin recalled.
More recalls from Stayma Consulting Service
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Duet DHA 400 ec, containing one bottle of multi-vitamin recalled | Stayma Consulting Service | Potency & Assay | Nationwide |
| Drug | CLASS III | Duet DHA 400, containing one bottle of multi-vitamin recalled | Stayma Consulting Service | Potency & Assay | Nationwide |
| Drug | CLASS III | Duet DHA 430, containing one bottle of multi-vitamin recalled | Stayma Consulting Service | Potency & Assay | Nationwide |
| Drug | CLASS III | Duet DHA 430 ec, containing one bottle of multi-vitamin recalled | Stayma Consulting Service | Potency & Assay | Nationwide |
| Drug | CLASS III | NataChew, one bottle of multi-vitamin tablets (imprinted 902) recalled | Stayma Consulting Service | Potency & Assay | Nationwide |