Mylan Recalls Candesartan Cilexetil and Hydrochlorothiazide Tablets Due to Impurity
Mylan Pharmaceuticals is recalling specific lots of Candesartan Cilexetil and Hydrochlorothiazide tablets due to out-of-specification organic impurities found during routine stability testing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 10,695 bottles of Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg. The affected products are packaged in 90-count bottles (NDC 0378-3002-77) and 500-count bottles (NDC 0378-3002-05). The recall covers Lot #8095666 and Lot #3104664, both with an expiration date of July 2021.
The recall was initiated because out-of-specification organic impurity results were obtained during routine stability testing. The FDA has classified this recall as Class III, which indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences.
The affected products were distributed nationwide within the United States. Patients and healthcare providers should check their inventory for the specific lot numbers and NDC codes listed above. If the product is found, it should be returned to the pharmacy or distributor for a refund or replacement.
The recalled product
- Product
- CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE)
- Brand
- CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 10,695
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 (3)
- Lot #: a) 8095666
- Exp. Date July 2021 b) 3104664
- Exp. Date July 2021
UPCs (3)
- 0303783003771
- 0303783001777
- 0303783002774
Distribution
Distributed nationwide across the United States.
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