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
Reported: March 8, 2017 Initiated: February 15, 2017 #D-0508-2017
Product Description
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
Reason for Recall
Failed dissolution specifications - low dissolution results at S3 stage.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 4014 cartons
- Distribution
- U.S. Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 4014 cartons.
Why was this product recalled? ▼
Failed dissolution specifications - low dissolution results at S3 stage.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 8, 2017. Severity: Low. Recall number: D-0508-2017.
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