Cubicin Injection Recalled for Foreign Particulate Matter in Vials
Cubist Pharmaceuticals is recalling Cubicin (daptomycin) injection vials due to the presence of tiny black foreign particulate matter observed after reconstitution.
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 recall is classified as FDA Class I, which per the rubric mandates a minimum severity score of 4 (Severe).
Plain-English summary
Cubist Pharmaceuticals, Inc. is recalling 371,879 vials of CUBICIN (daptomycin for injection) 500 mg, NDC 67919-011-01. The recall is due to the presence of foreign particulate matter, described as tiny black specs, observed at the bottom of the vial following reconstitution.
The affected lots are CDC203 (Exp 12/2015), CDC207 (Exp 01/2016), CDC213 (Exp 02/2016), CDC217 (Exp 03/2016), CDC226 (Exp 04/2016), CDC234 and CDC235 (Exp 05/2016), and CDC243 and CDC246 (Exp 07/2016). These products were distributed nationwide and in Puerto Rico.
Healthcare providers and patients should stop using the affected vials and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc., Lexington, MA 02421, USA, NDC 67919-011-01
- Manufacturer
- Cubist Pharmaceuticals, Inc.
- Category
- Drug — Antibiotic Injection
- Affected units
- 371,879
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 (16)
- Lot #'s: CDC203
- Exp 12/2015
- CDC207
- Exp 01/2016
- CDC213
- Exp 02/2016
- CDC217
- Exp 03/2016
- CDC226
- Exp 04/2016
- CDC234
- CDC235
- Exp 05/2016
- CDC243
- CDC246
- Exp 07/2016.
Distribution
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