Anagrelide Capsules Recalled Due to Failed Dissolution Specifications
Teva Pharmaceuticals is recalling Anagrelide Capsules USP 0.5 mg nationwide due to failed dissolution specifications discovered during stability testing. The recall involves lot GD01090 (expired May 2022).
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as a Class I recall, establishing a minimum severity level of 4. Class I recalls represent situations with reasonable probability of serious adverse health consequences. Although no deaths, illnesses, or injuries are currently reported, failed dissolution specifications in a prescription medication could prevent proper drug delivery and potentially cause serious patient harm.
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling Anagrelide Capsules USP, 0.5 mg, 100-count bottles nationwide due to failed dissolution specifications identified during stability testing. Testing revealed out-of-specification results.
The recall involves approximately 4,224 cartons from lot number GD01090, which expired in May 2022. The product was distributed nationwide in the United States.
Patients who have this recalled medication should contact their healthcare provider or pharmacist. Those with the affected product should return it to their pharmacy for proper handling.
The recalled product
- Product
- Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Affected units
- 4,224
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 # GD01090
- Exp 05/2022
Distribution
Distributed nationwide across the United States.
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