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Serious recall: Injury is possible or has been reported. Take action promptly.

The Ritedose Corporation 2023-08-09 Health serious FDA
Health · FDA · Recall #FDA-D-0946-2023

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

Issued August 9, 2023 · The Ritedose Corporation

In August 2023, The Ritedose Corporation recalled the Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx…, a serious health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

CGMP deviation: product released prior to supplier approval.

What you should do

  1. 1 Stop using Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact The Ritedose Corporation to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
The Ritedose Corporation
Category
Health
Recall date
August 9, 2023
Units affected
Not reported
Sold at
Nationwide in the US
Recall number
FDA-D-0946-2023
Made in
United States
Issuing agency
FDA

In context

  • The Ritedose Corporation has 2 recalls in our database.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 903rd Health recall we've logged in 2023.
Read the official FDA notice

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