Reported Nov 11, 2015 · Terminated
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for:…
Vintage Pharmaceuticals LLC, dba Qualitest Pharmaceuticals
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals · 150 Vintage Dr NE · Huntsville, AL · 35811-8216
Is this the product you have?
- RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only
- Manufactured forQUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
- NDC0603-9418-58
- Lot codes and dates
- Lot #: L088L13A
- Expiry
12/15Lot #: L023F14A
- Expiry
5/16Lot#: L024F14A
- Expiry5/16
- Amount recalled
- 61,146 Bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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