Boehringer Ingelheim Roxane Recalls Subpotent Acarbose Tablets
Boehringer Ingelheim Roxane Inc is recalling Acarbose 50 mg tablets because potency was below specification at a 9-month stability time point.
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, which typically corresponds to a moderate severity level. The hazard is subpotency, which may reduce efficacy but is not associated with immediate serious injury or death in the source text.
Plain-English summary
Boehringer Ingelheim Roxane Inc is recalling Acarbose Tablets 50 mg, a prescription medication used to treat type 2 diabetes. The recall involves 575 blister packs and 12,802 bottles of the drug, distributed nationwide and in Puerto Rico. The affected lots are 460073A and 460073B, both with an expiration date of 04/2016.
The recall was initiated after the firm received an out-of-specification result for Assay, indicating that the potency of the drug was below the required specification at the 9-month stability time point. This means the medication may not be as effective as intended.
Consumers and healthcare providers should stop using the affected Acarbose tablets and contact their healthcare provider for a replacement or alternative treatment. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ACARBOSE (ACARBOSE)
- Brand
- ACARBOSE
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Category
- Drug — Prescription Medication
- Hazard
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)
- a) Lot # 460073A Exp 04/2016 b) Lot # 460073B Exp 04/2016
UPCs (1)
- 0300540140250
Distribution
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