Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy Innovations, 2936 W 17th St.,
Summary
The FDA issued a Class II for Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, by Pharmacy Innovations. Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility..
Details
Source
Drug Recall
External ID
D-0199-2023
Action Date
2023-02-01
Status
Terminated
Category
drug
Product Description
Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lot/Code Info: t20221109@41
Quantity Affected: N/A
Reason for Recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-22
Company
Erie, PA
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 126 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Pharmacy Innovations has 59 FDA actions in our database, including 59 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 (Pharmacy Innovations) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pharmacy Innovations have FDA actions?
Pharmacy Innovations has 59 FDA actions in our database, including 59 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0199-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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