Reported Oct 19, 2016 · Terminated
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited,…
Dr. Reddy's Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
ZENATANE (isotretinoin capsules USP) 20 mg30 capsules per prescription packRx Only
- Manufactured byCipla Limited, Kurkumbh Village Pune 4138012 India
- Manufactured forDr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81
- Lot codes and dates
Lot # 79KB60205Exp. 02/18
- Amount recalled
- 3,858 prescription packs (115,680 capsules)
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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