D-0427-2021 Class II Terminated
FDA drug recall D-0427-2021 was initiated by Cardinal Health Inc. on March 15, 2021 and is designated Class II. Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage. The recall status is terminated (terminated June 17, 2024). Affected quantity: 38 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 2, 2021
- Initiation Date
- March 15, 2021
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38 bottles
Product Description
Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1 Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9
Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution Pattern
FL, GA, SC
Code Information
RT7113