Why it was recalled
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Product description
Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
Lot numbers, UPCs & expiration codes
Lot #: KB50361, KB50362, Exp 05/17; KB50540, Exp 07/17; KB50638, KB50639, Exp 08/17; KB50725, KB50726, KB50755, KB50756, Exp 09/17; 01KB60255, 79KB60252, 79KB60253, 79KB60254, Exp 03/18; 01KB60347, 01KB60348, 01KB60349, 01KB60350, 79KB60351, Exp 05/18; 01KB60421, 01KB60422, 01KB60423, 79KB60419, 79KB60420, Exp 06/18
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0884-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 22, 2017
- FDA report date
- Jun 14, 2017
- Quantity
- 89,118 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0884-2017, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77353
- Address
- 107 College Rd E
- Code information
- Lot #: KB50361, KB50362, Exp 05/17; KB50540, Exp 07/17; KB50638, KB50639, Exp 08/17; KB50725, KB50726, KB50755, KB50756, Exp 09/17; 01KB60255, 79KB60252, 79KB60253, 79KB60254, Exp 03/18; 01KB60347, 01KB60348, 01KB60349, 01KB60350, 79KB60351, Exp 05/18; 01KB60421, 01KB60422, 01KB60423, 79KB60419, 79KB60420, Exp 06/18
- Postal code
- 08540-6623
- Report date
- Jun 14, 2017
- Product type
- Drugs
- Recall number
- D-0884-2017
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 89,118 cartons
- Termination date
- Nov 19, 2018
- Reason for recall
- Failed Dissolution Specifications: out of specification results observed for low dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- May 22, 2017
- Initial firm notification
- Letter
- Center classification date
- Jun 2, 2017