Takeda Recalls Actoplus met XR Tablets Due to Defective Delivery System
Takeda is recalling Actoplus met XR tablets because the laser-drilled holes on the metformin core may be missing, potentially affecting drug delivery.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. No specific injuries or illnesses are reported in the source text.
Plain-English summary
Takeda Development Center Americas, Inc. is recalling Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, 30 tablet bottles. The recall involves 7,248 bottles distributed in Arkansas, Louisiana, Mississippi, North Carolina, New Jersey, Ohio, Pennsylvania, South Carolina, and Puerto Rico. Affected lots include A26004 (expiring April 2020) and A26443 and A26444 (expiring September 2020).
The recall is due to a defective delivery system where the tablets may be missing, in whole or in part, the laser-drilled holes on the metformin core. This defect could impact the intended release of the medication. The agency has classified this as a Class II recall.
Consumers should check their medication bottles for the specific lot numbers and expiration dates listed above. If the product matches the recalled items, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Takeda Pharmaceuticals America, Inc, Deerfield, IL 60015. NDC: 64764-510-30
- Manufacturer
- Takeda Development Center Americas, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 7,248
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 (5)
- Lot
- expiry: A26004
- exp Apr 2020
- A26443 and A26444
- exp Sep 2020
Distribution
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