Class III
Terminated
Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-521-01.
- Recall Initiated
- January 30, 2019
- Posted
- February 20, 2019
- Recall Number
- D-0491-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 23,884 bottles
- Firm Location
- Bridgewater, NJ, United States
Reason for Recall
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Distribution
Nationwide in the USA and Puerto Rico
Lot / Code Info
Lots: 18J035P, 18K094P, 18K093P, Exp 09/2020
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