Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a
Summary
The FDA issued a Class I for Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. by MERCK SHARP & DOHME CORP. Reason: Presence of Particulate Matter: Identified as Glass Particles.
Details
Source
Drug Recall
External ID
D-0093-2022
Action Date
2021-11-10
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot #: 934778, Exp. Date Jun 2022
Quantity Affected: 76,163 vials
Reason for Recall
Presence of Particulate Matter: Identified as Glass Particles
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-19
Company
Whitehouse Station, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 79 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
MERCK SHARP & DOHME CORP has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MERCK SHARP & DOHME CORP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MERCK SHARP & DOHME CORP have FDA actions?
MERCK SHARP & DOHME CORP has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0093-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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