Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp.... — FDA record D-0093-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 19, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
Reason
Presence of Particulate Matter: Identified as Glass Particles
Classification
Class I
Recalling firm
MERCK SHARP & DOHME CORP
Quantity
76,163 vials
Agency-reported status
Terminated
Source record identifier
D-0093-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLot #: 934778, Exp. Date Jun 2022

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide within the United States

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Nov 10, 2021
Recall initiation date
Oct 19, 2021
Center classification date
Nov 3, 2021
Termination date
Jul 25, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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