Cubicin daptomycin injection recalled for glass particle contamination
Merck Sharp & Dohme Corp. is recalling Cubicin (daptomycin for injection) 500 mg vials due to the presence of glass particles. The recall affects a single lot distributed nationwide.
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: This is an FDA Class I recall as stated in the source metadata. Class I recalls are assigned a minimum severity score of 4 per the rubric. The presence of glass particles in an injectable drug poses a risk of serious injury or harm to patients who may receive contaminated doses.
Plain-English summary
Merck Sharp & Dohme Corp. is recalling Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only, manufactured by Baxter Pharmaceuticals LLC. in Bloomington, Indiana. The recall was initiated due to the presence of particulate matter identified as glass particles in the product.
The affected product is Lot #934778 with an expiration date of June 2022, NDC 67919-011-01. Approximately 76,163 vials were distributed nationwide within the United States.
Patients who have received injections from affected vials should consult their healthcare provider. Healthcare providers should quarantine remaining stock from this lot and return it to the manufacturer or authorized wholesaler for credit or replacement.
The recalled product
- Product
- Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01
- Manufacturer
- MERCK SHARP & DOHME CORP
- Category
- Drug — Prescription Injectable
- Affected units
- 76,163
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 #: 934778
- Exp. Date Jun 2022
Distribution
Distributed nationwide across the United States.
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