OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21
Reported: September 10, 2014 Initiated: August 27, 2014 #D-1572-2014
Product Description
OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21
Reason for Recall
Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
Details
- Recalling Firm
- Qualitest Pharmaceuticals
- Units Affected
- 23,544 bottles
- Distribution
- Nationwide
- Location
- Huntsville, AL
Frequently Asked Questions
What product was recalled? ▼
OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21. Recalled by Qualitest Pharmaceuticals. Units affected: 23,544 bottles.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 10, 2014. Severity: Moderate. Recall number: D-1572-2014.
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