Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not
Summary
The FDA issued a Class II for Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per c by The Ritedose Corporation. Reason: CGMP deviation: product released prior to supplier approval..
Details
Source
Drug Recall
External ID
D-0946-2023
Action Date
2023-08-09
Status
Completed
Category
drug
Product Description
Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not For Inhalation or Injection, Must be Diluted, Manufactured by: The Ritedose Corporation Columbia, SC 29203 for Ritedose Pharmaceuticals, LLC Columbia, SC 29203, NDC 76204-025-96.
Lot/Code Info: Lot: 23CE2, Exp. 03/31/2026
Quantity Affected: 44 cartons
Reason for Recall
CGMP deviation: product released prior to supplier approval.
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-21
Company
Columbia, SC
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 171 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
The Ritedose Corporation has 3 FDA actions in our database, including 2 recalls and 1 clearance.
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 (The Ritedose Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Ritedose Corporation have FDA actions?
The Ritedose Corporation has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0946-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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