BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281
Summary
The FDA issued a Class I for BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, by Med Shop Total Care Inc.. Reason: Non-Sterility.
Details
Source
Drug Recall
External ID
D-0705-2021
Action Date
2021-08-18
Status
Terminated
Category
drug
Product Description
BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Lot/Code Info: Lot #: 09282020@38 BUD: 10/29/2020
Quantity Affected: 41 mL
Reason for Recall
Non-Sterility
Distribution
Texas and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2020-10-05
Company
Longview, 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 41 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Med Shop Total Care Inc. has 14 FDA actions in our database, including 14 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 (Med Shop Total Care Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Med Shop Total Care Inc. have FDA actions?
Med Shop Total Care Inc. has 14 FDA actions in our database, including 14 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0705-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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