Recalls / Class III
Class IIID-0162-2016
Product
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.
- Affected lot / code info
- Lot #: L088L13A, Expiry: 12/15; Lot #: L023F14A, Expiry: 5/16; Lot#: L024F14A, Expiry: 5/16.
Why it was recalled
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Recalling firm
- Firm
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Vintage Dr NE, N/A, Huntsville, Alabama 35811-8216
Distribution
- Quantity
- 61,146 Bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2015-10-21
- FDA classified
- 2015-11-02
- Posted by FDA
- 2015-11-11
- Terminated
- 2016-10-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0162-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.