Class II · Moderate risk
Enoxaparin Sodium Injection
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement Rx NDC 64661-650-30 Manufactured for: JAYMAC Pharmaceuticals, LLC, Sunset, LA 70584
Affected NDC
64661-0650-30
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| EnBrace HR 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 NDC 64661-0650 |
LEVOMEFOLATE MAGNESIUM 5.23 mg/1; LEUCOVORIN 2.5 mg/1; FOLIC ACID 1 mg/1; FERROUS CYSTEINE GLYCINATE 13.6 mg/1; MAGNESIUM ASCORBATE 24 mg/1; ZINC ASCORBATE 1 mg/1; COCARBOXYLASE 25 ug/1; FLAVIN ADENINE DINUCLEOTIDE 25 ug/1; NADH 25 ug/1; PYRIDOXAL PHOSPHATE ANHYDROUS 25 ug/1; COBAMAMIDE 50 ug/1; BETAINE 500 ug/1; MAGNESIUM L-THREONATE 1 mg/1; 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 6.4 mg/1; 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 800 ug/1; PHOSPHATIDYL SERINE 12 mg/1 | Capsule, Delayed Release Pellets Oral |
Jaymac Pharmaceuticals, LLC | Rx |
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 64661-650-30
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0496-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Cardinal Health Inc.
All 2021 recalls
Class II · Moderate risk
Recombinate
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Other temperature excursion recalls from 2021
All temperature excursion recalls
Class I · High risk
Enoxaparin Sodium Injection
Temperature Abuse; temperature excursion during shipping
Class I · High risk
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
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