Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2 recall: CGMP Deviations
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
Why was Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2 recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
RT7113
- Product
- 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
- Recalling firm
- Cardinal Health Inc.
- Quantity
- 38 bottles
- Distribution
- FL, GA, SC
- Recall date
- June 2, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)