Verapamil Hydrochloride Tablets Recalled for Failed Dissolution Specification
Amerisource Health Services LLC is recalling 422 cartons of Verapamil Hydrochloride Extended-Release Tablets, 120 mg due to failed dissolution testing. The tablets did not meet specifications for drug release.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a dissolution specification failure that could affect drug bioavailability. Though no illnesses or injuries have been reported, the failure represents a risk-of-harm scenario for an extended-release cardiac medication where proper drug delivery is critical.
Plain-English summary
Amerisource Health Services LLC is recalling Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg (NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11) distributed nationwide. The recall is due to failed dissolution specification testing. Testing found out-of-specification dissolution results at the initial time point, with values exceeding the specifications, indicating the tablets may not properly release the medication in the body.
The recall affects Lot 1009065 with an expiration date of December 31, 2023. Approximately 422 cartons were distributed nationwide in the United States.
Consumers with this medication should contact their pharmacist or healthcare provider regarding this recall.
The recalled product
- Product
- Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Hazard
- Affected units
- 422
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 1009065
- Exp 12/31/2023
Distribution
Distributed nationwide across the United States.
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