Reported Jun 14, 2017 · Terminated
Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured…
Dr. Reddy's Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only
- Manufactured ByCipla Limited, Kurkumbh Village, Pune 413802 India
- Manufactured For
Dr. Reddy's LaboratoriesBachupally 500 090 IndiaNDC 55111-136-81
- Lot codes and dates
Lot #: KB50361KB50362Exp 05/17KB50540Exp 07/17KB50638KB50639Exp 08/17KB50725KB50726KB50755KB50756Exp 09/1701KB6025579KB6025279KB6025379KB60254Exp 03/1801KB6034701KB6034801KB6034901KB6035079KB60351Exp 05/1801KB6042101KB6042201KB6042379KB6041979KB60420Exp 06/18
- Amount recalled
- 89,118 cartons
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Dissolution Specifications: out of specification results observed for low dissolution.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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