Class II · Moderate risk Terminated
Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply
Reason Lack of Processing Controls.
Is Glatiramer recalled?
4 FDA recalls mention Glatiramer. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Glatiramer.
Class II · Moderate risk Terminated
Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and…
Reason Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
Class II · Moderate risk Terminated
Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs)…
Reason Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of…
Class II · Moderate risk Terminated
Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30
Reason Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
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