Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
Reported: January 25, 2023 Initiated: December 28, 2022 #D-0159-2023
Product Description
Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
Reason for Recall
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Details
- Recalling Firm
- Ascend Laboratories, LLC
- Units Affected
- 12192 bottles
- Distribution
- Customers in 19 states: CA, FL, GA, IL, KY, LA, MI, MN, MS, NC, NJ, NY, OH, PA, RI, TN, TX, WA, WI; Puerto Rico
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Recalled by Ascend Laboratories, LLC. Units affected: 12192 bottles.
Why was this product recalled? ▼
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 25, 2023. Severity: Moderate. Recall number: D-0159-2023.
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