Is Enoxaparin recalled?
7 FDA recalls mention Enoxaparin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Enoxaparin.
Class II · Moderate risk Ongoing
Reason Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class II · Moderate risk Terminated
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class I · High risk Completed
Reason Temperature Abuse; temperature excursion during shipping
Class II · Moderate risk Terminated
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I · High risk Ongoing
Reason Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding…
Class I · High risk Ongoing
Reason Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings…
Class III · Low risk Terminated
Reason Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL