TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML For
Summary
The FDA issued a Class II for TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged i by Drug Depot, Inc., dba APS Pharmacy. Reason: Lack of sterility assurance..
Details
Source
Drug Recall
External ID
D-0730-2022
Action Date
2022-04-06
Status
Terminated
Category
drug
Product Description
TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b) (RM) 10 ML Formula ID 115125; APS Pharmacy
Lot/Code Info: Lots: a) 745383 BUD: 6/20/2022; 759295 BUD: 8/30/2022; b) 745749 BUD: 6/21/2022; 746272 BUD: 6/27/2022
Quantity Affected: 846 vials
Reason for Recall
Lack of sterility assurance.
Distribution
Nationwide in the USA including Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-23
Company
Palm Harbor, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 81 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Drug Depot, Inc., dba APS Pharmacy has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Drug Depot, Inc., dba APS Pharmacy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Drug Depot, Inc., dba APS Pharmacy have FDA actions?
Drug Depot, Inc., dba APS Pharmacy has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0730-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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