The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-1382-2014·Announced 2014-06-18

Cubist Recalls CUBICIN Vials Due to Glass Shard Presence

Cubist Pharmaceuticals is recalling 51,500 vials of CUBICIN (daptomycin) because a customer reported a glass shard in one vial.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.

Plain-English summary

Cubist Pharmaceuticals, Inc. is recalling 51,500 vials of CUBICIN (daptomycin for injection), 500 mg single-use vials. The recall was initiated after a customer complaint reported that one vial contained a glass shard.

The affected product is identified by Lot # 280453F with an expiration date of 04/16. The NDC is 67919-011-01 and the UPC is 3 67919-011-01 6. The product was distributed nationwide and in Puerto Rico.

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

The recalled product

Product
CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.
Manufacturer
Cubist Pharmaceuticals, Inc.
Category
Drug — Injectable Antibiotic
Hazard
Affected units
51,500

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 #: 280453F
  • Exp 04/16

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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