RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
Reported: November 11, 2015 Initiated: October 21, 2015 #D-0162-2016
Product Description
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
Reason for Recall
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Details
- Recalling Firm
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Units Affected
- 61,146 Bottles
- Distribution
- U.S. Nationwide
- Location
- Huntsville, AL
Frequently Asked Questions
What product was recalled? ▼
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.. Recalled by Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals. Units affected: 61,146 Bottles.
Why was this product recalled? ▼
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 11, 2015. Severity: Low. Recall number: D-0162-2016.
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