Drug 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.
D-0162-2016
Product summary
- Event
- Event 72493
- Status
- Terminated
- Classification
- Class III
- Quantity
- 61,146 Bottles
- Official record key
drug-enforcement:D-0162-2016
Official wording
Reason: Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Code information: Lot #: L088L13A, Expiry: 12/15; Lot #: L023F14A, Expiry: 5/16; Lot#: L024F14A, Expiry: 5/16.
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Out of Specification