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
Reported: June 2, 2021 Initiated: March 15, 2021 #D-0427-2021
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.
Details
- Recalling Firm
- Cardinal Health Inc.
- Units Affected
- 38 bottles
- Distribution
- FL, GA, SC
- Location
- Dublin, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cardinal Health Inc.. Units affected: 38 bottles.
Why was this product recalled? ▼
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0427-2021.
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