Voluntary Recall of Docetaxel Injection, USP due to Potential Presence of Particulate Matter

Port of Spain, June 07, 2024: The Ministry of Health (MoH), via its Chemistry, Food and Drugs Division advises of the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials). The recall was issued by the international distributor, Sagent Pharmaceuticals due to potential presence of particulate matter from the stopper in the drug product.

Docetaxel Injection, USP is indicated for the treatment of patients with certain types of cancers. The label and affected lot numbers with Expiration Dates and NDC number can be found in the table below.

While the recalled products are not registered for use in Trinidad and Tobago, out of an abundance of caution, the Ministry advises persons who may be in possession of these recalled products to discontinue use immediately and to return the product to the place of purchase where possible.

Additional Information can be obtained by contacting the Office of the Director of the Chemistry, Food and Drugs Division via email at cfdd@health.gov.tt or phone at 217-4664 ext. 13101.

The Ministry of Health will continue to monitor the situation and advise the population as necessary.

RECALLED PRODUCTS

ProductLot NumberNDCExpiration DateStrength
DOCETAXEL
INJECTION, USP
F1030001
 
F1040001
25021-254-16
 
25021-254-08
12/2024
 
12/2024
160 mg/16 mL
(10 mg/mL)
 
80 mg/8 mL
(10 mg/mL)

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