FDA recall D-0946-2023

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.

Reason for recall

CGMP deviation: product released prior to supplier approval.

Distribution

Nationwide in the US

Key facts

Status

Completed

Initiation date

2023-07-21

Report date

2023-08-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbia, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0946-2023