Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Kroger Specialty Pharmacy, Inc.

NDC code

00378-6961-12

Origin

MS, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0778-2018

Other Glatiramer recalls

See all

Class II · Moderate risk Terminated Oct 24, 2013

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.

Teva Pharmaceuticals USA NDC 68546-317-30 D-001-2014

Class II · Moderate risk Terminated Dec 5, 2012

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…

Teva Pharmaceuticals USA, Inc. NDC 68546-317-30 D-249-2013

Class II · Moderate risk Terminated May 18, 2012

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.

Teva Pharmaceuticals USA, Inc. NDC 68546-317-30 D-1442-2012