Class III
Terminated
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.
- Recall Initiated
- October 21, 2015
- Posted
- November 11, 2015
- Recall Number
- D-0162-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 61,146 Bottles
- Firm Location
- Huntsville, AL, United States
Reason for Recall
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Distribution
U.S. Nationwide
Lot / Code Info
Lot #: L088L13A, Expiry: 12/15; Lot #: L023F14A, Expiry: 5/16; Lot#: L024F14A, Expiry: 5/16.
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