CLASS III Drug recall · Reported 4 Jan 2017 · FDA Enforcement Report
Extra-Virt Plus DHA Prenatal/Postnatal Softgel recalled
Virtus Pharmaceuticals Opco Ii L is recalling Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary, distributed nationwide in the US. The recall was initiated on 12 Dec 2016 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-0239-2017
- FDA event ID
- 76103
- Recalling firm
- Virtus Pharmaceuticals Opco Ii L, Nashville, TN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Dec 2016
- FDA classified
- 28 Dec 2016
- Reported
- 4 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 12 Dec 2016 | Recall initiated by company | |
| 28 Dec 2016 | Classified by FDA | +16 days |
| 4 Jan 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Product as listed by the FDA
Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-251-30
Where it was distributed
Nationwide
Questions about this recall
Is Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary recalled?
Yes. Virtus Pharmaceuticals Opco Ii L recalled Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary on 12 Dec 2016. The recall is Class III and its status is Terminated. Recall number D-0239-2017.
Why was it recalled?
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Which lots are affected?
Lots #: 21511137 Exp. date 10/30/2017
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Virtus Pharmaceuticals Opco Ii L
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | VirtPrex Prenatal/Postnatal Tablets recalled | Virtus Pharmaceuticals Opco Ii L | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Virt-Advance Prenatal/Postnatal Softgels recalled | Virtus Pharmaceuticals Opco Ii L | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Virt-Select Prenatal/Postnatal Softgels recalled | Virtus Pharmaceuticals Opco Ii L | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Hyoscyamine Sulfate, USP Tablets recalled by Virtus Pharmaceuticals Opco | Virtus Pharmaceuticals Opco Ii L | Potency & Assay | Nationwide |
| Drug | CLASS I | Hyoscyamine Sulfate, Sublingual Tablets, 125 mg recalled | Virtus Pharmaceuticals Opco Ii L | Potency & Assay | Nationwide |