Genentech Recalls Klonopin Tablets Due to Missing Schedule IV Labeling
Genentech is recalling Klonopin (clonazepam) 0.5 mg tablets because the Schedule IV controlled substance indicator was omitted from the product carton.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error on the carton only, with the primary label remaining correct.
Plain-English summary
Genentech, Inc. is recalling 3,192 bottles of Klonopin (clonazepam) 0.5 mg tablets, 100-count bottles, due to a labeling error. The product is distributed throughout the United States. The specific lot affected is # 3141989, with an expiration date of 08/31/2019.
The recall was initiated because the Schedule IV controlled substance indicator (CIV) was omitted from the product carton. The primary label on the bottle is correct. This is a Class III recall, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for Klonopin (clonazepam) 0.5 mg tablets with Lot # 3141989. If found, the product should be returned to the pharmacy or distributor for replacement or refund. Patients should continue to take their medication as prescribed, as the primary label is accurate and the medication itself is not compromised.
The recalled product
- Product
- 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
- Manufacturer
- Genentech, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,192
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 3141989
- EXP 08/31/2019
Distribution
Distribution scope not specified by the agency.
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