Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1515-2019·Announced 2019-07-31

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.

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 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: failed-dissolution

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.

Same manufacturer · Ascend Laboratories LLC

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