FDARecalled Jun 7, 2023 · #D-0780-2023
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Hazard
Class II — temporary health risk
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CGMP Deviations: Firm went out of business and could no longer continue stability studies. Classification: Class II Distribution: Nationwide in the USA and Puerto Rico
Product details
- Product
- Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
- Type
- Drugs
- Manufacturer
- Akorn, Inc.
- Model numbers
- —
- UPCs
- —