The Recall Desk
SevereFDA (Drugs)·D-764-2014·Announced 2014-01-29

Cubicin Injection Recalled for Glass Particulates in Vials

Cubist Pharmaceuticals is recalling 179,870 vials of Cubicin (daptomycin for injection) due to the presence of glass particulates.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class I recall, which the rubric defines as a minimum of 4 (Severe) due to the potential for serious adverse health consequences.

Plain-English summary

Cubist Pharmaceuticals, Inc. is recalling 179,870 vials of Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials. The recall is being conducted because glass particulates were observed in the vials.

The affected product is distributed nationwide. The recall includes specific lot numbers: Lot 950453F (Exp. 12/06/2013), Lot 090203F (Exp. 09/07/2014), Lot 201703F (Exp. 08/31/2015), and Lot 201653F (Exp. 09/01/2015).

Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the manufacturer for further instructions.

The recalled product

Product
Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA
Manufacturer
Cubist Pharmaceuticals, Inc.
Category
Drug — Antibiotic
Hazard
Affected units
179,870

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 (5)

  • Lot Numbers: Lot 950453F
  • Exp. 12/06/2013 Lot 090203F
  • Exp. 09/07/2014 Lot 201703F
  • Exp. 08/31/2015 Lot 201653F
  • Exp. 09/01/2015

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Cubist Pharmaceuticals, Inc.

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Same hazard · glass particulates

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