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Class II: temporary or reversible health riskCompleted

The Ritedose Cromolyn Sodium Oral Solution Recall

Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton,…

The Ritedose Corporation · Columbia, SC

Risk level
Class II
Reported by FDA
Aug 9, 2023
Recall ID
D-0946-2023
Check your lot numberHow we source this data

Summary

The Ritedose recalled Cromolyn Sodium Oral Solution starting Jul 21, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0946-2023 on Aug 9, 2023. Reason: CGMP deviation: product released prior to supplier approval. Status: Completed.

Why it was recalled

CGMP deviation: product released prior to supplier approval.

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 numbers, UPCs & expiration codes

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

Where it was sold

Nationwide in the US

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0946-2023
Classification
Class II
Status
Completed
Recall initiated
Jul 21, 2023
FDA report date
Aug 9, 2023
Quantity
44 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
The Ritedose Corporation

Original FDA data

Every field from FDA enforcement report D-0946-2023, exactly as published.

Show all FDA fields
City
Columbia
State
SC
Status
Completed
Country
United States
Event ID
92754
Address
1 Technology Cir
Code information
Lot: 23CE2, Exp. 03/31/2026
Postal code
29203-9591
Report date
Aug 9, 2023
Product type
Drugs
Recall number
D-0946-2023
Classification
Class II
Recalling firm
The Ritedose Corporation
Product quantity
44 cartons
Reason for recall
CGMP deviation: product released prior to supplier approval.
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide in the US
Recall initiation date
Jul 21, 2023
Initial firm notification
E-Mail
Center classification date
Jul 31, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0946-2023, published Aug 9, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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