Reported Jun 14, 2017 · Terminated
Zenatane (isotretinoin) Capsules, USP, 30 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, 30 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 55111-113-81
- Lot codes and dates
12 of 12 products
Products covered by this recall # Product as published 1 KB50414, KB50456, Exp 05/17 2 KB50457, KB50458, KB50459, KB50460, Exp 06/17 3 KB50580, KB50581, KB50582, KB50583, KB50599, KB50600, Exp 07/17 4 KB50646, KB50647, KB50721, KB50722, KB50723, KB50724, Exp 09/17 5 KB50833, KB50834, KB50835, KB50836, KB50837, Exp 10/17 6 KB50902, KB50903, KB50904, Exp 11/17 7 KB60037, KB60038, KB60039, KB60040, KB60041, Exp 12/17 8 KB60109, KB60110, KB60111, KB60112, KB60113, Exp 01/18 9 01KB60249, 01KB60266, 01KB60268, 01KB60269, 01KB60284, Exp 03/18 10 01KB60369, 01KB60372, 79KB60368, 79KB60371, Exp 05/18 11 79KB60507, 79KB60508, 79KB60509, 79KB60510, 79KB60511, 79KB60512, 79KB60513, 79KB60514, 79KB60515, 79KB60516, Exp 07/18 12 79KB60570, 79KB60571, 79KB60585, 79KB60586, Exp 08/18 - Amount recalled
- 223,650 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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