Recalls / Class II
Class IID-0496-2021
Product
Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement Rx NDC 64661-650-30 Manufactured for: JAYMAC Pharmaceuticals, LLC, Sunset, LA 70584
- Brand name
- Enbrace Hr
- Generic name
- Levomefolate Magnesium, Leucovorin, Folic Acid, Ferrous Cysteine Glycinate, Magnesium Ascorbate, Zinc Ascorbate, Cocarboxylase, Flavin Adenine Dinucleotide, Nadh, Pyridoxal Phosphate Anhydrous, Cobamamide, Betaine, Magnesium L-threonate, 1,2-docosahexanoyl-sn-glycero-3-phosphoserine Calcium, 1,2-icosapentoyl-sn-glycero-3-phosphoserine Calcium, And Phosphatidyl Serine
- Active ingredients
- 1,2-docosahexanoyl-sn-glycero-3-phosphoserine Calcium, 1,2-icosapentoyl-sn-glycero-3-phosphoserine Calcium, Betaine, Cobamamide, Cocarboxylase, Ferrous Cysteine Glycinate, Flavin Adenine Dinucleotide, Folic Acid, Leucovorin, Levomefolate Magnesium, Magnesium Ascorbate, Magnesium L-threonate, Nadh, Phosphatidyl Serine, Pyridoxal Phosphate Anhydrous, Zinc Ascorbate
- Route
- Oral
- NDC
- 64661-650
- Affected lot / code info
- All Lots distributed 02/23/2021 through 03/10/2021.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Jaymac Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 11 bottles
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0496-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.