July 2023 FDA Recall Cromolyn Sodium Oral Solution (concentrate) by The Ritedose Corporation (D-0946-2023 - CGMP deviation)

This Class II drug recall was voluntarily initiated by The Ritedose Corporation on July 21, 2023 for the product Cromolyn Sodium Oral Solution (concentrate). The FDA reported the reason for recall as cgmp deviation. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0946-2023

Reason for Recall
CGMP deviation: product released prior to supplier approval.
Initiated
07-21-2023
Reported
08-09-2023
Quantity
44 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92754
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Ritedose Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# Lot: 23CE2, Exp. 03/31/2026

Affected Packages Involved in this Recall

76204-025-08 Cromolyn Sodium Oral Solution (concentrate)
76204-025-96 Cromolyn Sodium Oral Solution (concentrate)