Actavis Recalls Clonazepam Tablets Due to Subpotent Tablet Weight
Actavis Elizabeth LLC is recalling 13,608 bottles of Clonazepam 2 mg tablets because routine testing found one tablet with weight below specification.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a subpotent drug issue found during routine testing without reports of patient harm or illness, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Actavis Elizabeth LLC is voluntarily recalling 13,608 bottles of Clonazepam Tablets, USP 2 mg (NDC 0228-3005-11). The affected product is Lot 58468552 with an expiration date of 05/15. The bottles are packaged in white/round HDPE containers and shipped in corrugated cartons.
The recall was initiated after routine stability testing identified one tablet with a weight below the specified standard. This indicates the tablets may be subpotent, meaning they may not contain the full intended amount of the active ingredient.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or distributor for a refund or replacement.
The recalled product
- Product
- Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton)
- Manufacturer
- Actavis Elizabeth LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 13,608
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 (1)
- lot 58468552 Exp. 05/15
Distribution
Distributed nationwide across the United States.
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