Why it was recalled
Failed dissolution specifications - low dissolution results at S3 stage.
Product description
Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 5511-113-81
Lot numbers, UPCs & expiration codes
Lot # KB60036, Exp 12/17
Where it was sold
U.S. Nationwide
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-0508-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 15, 2017
- FDA report date
- Mar 8, 2017
- Quantity
- 4014 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0508-2017, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76539
- Address
- 107 College Rd E
- Code information
- Lot # KB60036, Exp 12/17
- Postal code
- 08540-6623
- Report date
- Mar 8, 2017
- Product type
- Drugs
- Recall number
- D-0508-2017
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 4014 cartons
- Termination date
- Dec 19, 2018
- Reason for recall
- Failed dissolution specifications - low dissolution results at S3 stage.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 5511-113-81
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Feb 15, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 2, 2017