Class II · Moderate risk Terminated
Copaxone
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.
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.
Why it was recalled
Lack of Processing Controls.
What was recalled
Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply
- 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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Glatiramer recalls
See all
Class II · Moderate risk Terminated
Copaxone
Reason Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
Class II · Moderate risk Terminated
Copaxone
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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