Reported Jun 14, 2017 · Terminated
Zenatane (isotretinoin) Capsules, USP, 40 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, 40 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 55111-137-81
- Lot codes and dates
116 of 116 codes
Lot #: KB50363KB50364KB50365KB50366KB50367KB50368KB50369KB50370KB50371Exp 05/1701KB50598KB50541KB50542KB50543KB50544KB50545KB50546KB50547KB50548KB50549KB50550KB50551Exp 07/1701KB5064301KB50644KB50640KB50641KB50642KB50645Exp 08/17KB50715KB50716KB50717KB50718KB50719KB50720KB50757KB50758KB50759KB50760KB50761Exp 09/17KB50872KB50874KB50875KB50876KB50916KB50938KB50943Exp 11/1701KB6006201KB6006301KB6006401KB6006501KB6006601KB60101KB60025KB60026KB60027KB60028
- Amount recalled
- 452,290 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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