Class II · Moderate risk
Copaxone 20 mg Injection PFS
Lack of Processing Controls.
National Drug Code
Is NDC 68546-0317-30 recalled?
Copaxone · 30 BLISTER PACK in 1 CARTON (68546-317-30) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
Yes — this exact package was recalled
4 FDA recalls name the code 68546-0317-30 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Glatiramer Acetate
- Strength
- GLATIRAMER ACETATE 20 mg/mL
- Form
- Injection, Solution · Subcutaneous
- Labeler
- Teva Neuroscience, Inc.
- Type
- Human Prescription Drug
- Product code
- 68546-0317
Recalls naming this package
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.
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.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 68546-0142 Azilect 1
- 68546-0325 Copaxone 1
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