Class III
Terminated
Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 5511-113-81
This recall has been terminated (originally issued March 8, 2017).
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- February 15, 2017
- Posted
- March 8, 2017
- Recall Number
- D-0508-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4014 cartons
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed dissolution specifications - low dissolution results at S3 stage.
Distribution
U.S. Nationwide
Lot / Code Info
Lot # KB60036, Exp 12/17
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