Class II · Moderate risk
Copaxone (glatiramer acetate injection)
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.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply
Affected NDC
0378-6961-12
Compare with the code on your package — it is the most precise check available.
Drug: Glatiramer
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 |
|---|---|---|---|---|
| Glatiramer Acetate Glatiramer NDC 00378-6961 |
ACETATE 40 mg/mL | Injection, Solution Subcutaneous |
Mylan Pharmaceuticals Inc. | Rx |
- 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 · 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 Glatiramer recalls
See all
Class II · Moderate risk
Copaxone (glatiramer acetate injection)
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
Copaxone (glatiramer acetate injection)
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Other recalls by Kroger Specialty Pharmacy, Inc.
All 2018 recalls
Class II · Moderate risk
Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
Lack of Processing Controls.
Class II · Moderate risk
Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
Lack of Processing Controls.
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