Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pha
Summary
The FDA issued a Class I for Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This i by Revive Rx LLC dba Revive Rx Pharmacy. Reason: Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate.
Details
Source
Drug Recall
External ID
D-0511-2024
Action Date
2024-06-05
Status
Ongoing
Category
drug
Product Description
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64
Lot/Code Info: Lot #: 748127, Exp 9/24/2024
Quantity Affected: 751 vials
Reason for Recall
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-20
Company
Houston, TX
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 115 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Revive Rx LLC dba Revive Rx Pharmacy has 3 FDA actions in our database, including 3 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 (Revive Rx LLC dba Revive Rx Pharmacy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Revive Rx LLC dba Revive Rx Pharmacy have FDA actions?
Revive Rx LLC dba Revive Rx Pharmacy has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0511-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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