ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Reported: January 14, 2015 Initiated: December 22, 2014 #D-0331-2015
Product Description
ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Details
- Recalling Firm
- Qualitest Pharmaceuticals
- Units Affected
- a) 3936 bottles; b) 84420 bottles
- Distribution
- Nationwide
- Location
- Huntsville, AL
Frequently Asked Questions
What product was recalled? ▼
ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811. Recalled by Qualitest Pharmaceuticals. Units affected: a) 3936 bottles; b) 84420 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 14, 2015. Severity: Low. Recall number: D-0331-2015.
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