ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81
Reported: October 19, 2016 Initiated: August 29, 2016 #D-0098-2017
Product Description
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 3,858 prescription packs (115,680 capsules)
- Distribution
- nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 3,858 prescription packs (115,680 capsules).
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 19, 2016. Severity: Low. Recall number: D-0098-2017.
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