# FDA recall D-1515-2019

> **Ascend Laboratories LLC** · Class II · drug recall initiated 2019-07-19.

## 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

## Reason for recall

Failed Dissolution Specifications

## Distribution

Product was shipped to wholesalers throughout the United States.

## Key facts

- **Recall number:** D-1515-2019
- **Recalling firm:** Ascend Laboratories LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-07-19
- **Report date:** 2019-07-31
- **Termination date:** 2021-06-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1515-2019

## Citation

> AI Analytics. FDA recall D-1515-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1515-2019. Source: US FDA. Licensed CC0.

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