Ascend Recalls Atorvastatin Calcium Tablets for Failed Dissolution Specifications
Ascend Laboratories is recalling Atorvastatin Calcium 80 mg tablets because they failed dissolution specifications. The product was distributed to wholesalers nationwide.
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 involves a temporary or medically reversible adverse health consequence. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or mislabeling of a common allergen.
Plain-English summary
Ascend Laboratories, LLC is recalling Atorvastatin Calcium Tablet USP 80 mg, 90-count and 500-count bottles. The recall was initiated because the product failed dissolution specifications. The medication is manufactured by Alkem Laboratories, Ltd, in Mumbai, India, and distributed by Ascend Laboratories, LLC, in Parsippany, NJ.
The affected product includes specific lot numbers with expiration dates ranging from December 2020 to March 2021. The total quantity recalled is 5,472 bottles of the 90-count size and 5,880 bottles of the 500-count size. The product was shipped to wholesalers throughout the United States.
Consumers and healthcare providers should check their inventory for the specific NDC numbers and lot numbers listed in the recall notice. If the product is found, it should be returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider for alternative medication options if necessary.
The recalled product
- Product
- Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ
- Manufacturer
- Ascend Laboratories LLC
- 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 (11)
- a) Lot# 19140443
- exp. date 12/2020
- Lot# 19140525
- 19140535
- exp. date 01/2021 and b) Lot# 19140756
- Lot# 19140757
- Lot# 19140758
- exp. date 01/2021
- Lot# 19141696
- Lot# 19141793
- exp. date 03/2021
Distribution
Distribution scope not specified by the agency.
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