Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Summary
The FDA issued a Class II for Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV by BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy. Reason: Lack of sterility assurance.
Details
Source
Drug Recall
External ID
D-0702-2021
Action Date
2021-08-11
Status
Terminated
Category
drug
Product Description
Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkway, Temple Terrace, FL 33837
Lot/Code Info: Lot: SUCC10020210624 Exp. 09/22/2021
Quantity Affected: 253 syringes
Reason for Recall
Lack of sterility assurance
Distribution
FL
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-30
Company
Temple Terrace, 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 21 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy has 3 FDA actions in our database, including 3 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 (BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy have FDA actions?
BayCare Integrated Service Center, LLC /dba BayCare Central 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-0702-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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