Class III
Terminated
Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bottle (NDC 57664-247-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
This recall has been terminated (originally issued September 28, 2016).
- Recall Initiated
- June 27, 2016
- Posted
- September 28, 2016
- Recall Number
- D-1507-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,889 HDPE bottles
- Firm Location
- Cranbury, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide
Lot / Code Info
Lot # AVF0258/A, AVF0258/B, AVF0258/C, AVF0259/A, AVF0259/C; Exp. 02/17
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