The Recall Desk
HighFDA (Drugs)·D-1442-2012·Announced 2012-08-15

Teva Recalls Copaxone Injections Due to Foreign Particle Presence

Teva Pharmaceuticals is recalling specific lots of Copaxone (glatiramer acetate) injection due to the presence of a foreign particle identified from a customer complaint.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the presence of a foreign particle in an injectable medication poses a risk of harm, fitting the criteria for a High severity rating where injury has not yet been reported.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling 6,647 cartons of Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL, Rx only. The recall is being initiated due to the presence of a foreign particle identified from a customer complaint.

The affected product is Lot number X05011, with an expiration date of 08/13. The product was distributed nationwide. The specific NDC for the recalled product is 68546-317-30.

Healthcare providers and patients should check their inventory and medication supplies for this specific lot number. If the product is found, it should be returned to the pharmacy or healthcare provider for disposal or replacement according to standard recall procedures.

The recalled product

Product
COPAXONE (GLATIRAMER ACETATE)
Brand
COPAXONE
Manufacturer
Teva Pharmaceuticals USA, Inc.
Category
Drug — Prescription Injection
Hazard
Affected units
6,647

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot number X05011
  • Exp 08/13

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · COPAXONE

Same manufacturer · Teva Pharmaceuticals USA, Inc.

See all →