Summary
The FDA issued a Class I for Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455 by Pyramids Wholesale Inc.. Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil..
Details
Source
Drug Recall
External ID
D-0448-2024
Action Date
2024-05-01
Status
Ongoing
Category
drug
Product Description
Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
Lot/Code Info: All lots
Quantity Affected: 45 boxes
Reason for Recall
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-19
Company
Los Angeles, CA
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 96 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Pyramids Wholesale Inc. has 11 FDA actions in our database, including 11 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 (Pyramids Wholesale Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pyramids Wholesale Inc. have FDA actions?
Pyramids Wholesale Inc. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0448-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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