Why it was recalled
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
Product description
Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01
Lot numbers, UPCs & expiration codes
Lot # 3141989, EXP 08/31/2019
Where it was sold
Distributed throughout the United States
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-0416-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 5, 2018
- FDA report date
- Feb 21, 2018
- Quantity
- 3,192 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Genentech, Inc.
Original FDA data
Every field from FDA enforcement report D-0416-2018, exactly as published.
Show all FDA fields
- City
- South San Francisco
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 79175
- Address
- 1 Dna Way
- Code information
- Lot # 3141989, EXP 08/31/2019
- Postal code
- 94080-4990
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0416-2018
- Classification
- Class III
- Recalling firm
- Genentech, Inc.
- Product quantity
- 3,192 bottles
- Termination date
- Sep 6, 2018
- Reason for recall
- Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01
- Distribution pattern
- Distributed throughout the United States
- Recall initiation date
- Feb 5, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 13, 2018