Why it was recalled
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
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
Lot numbers, UPCs & expiration codes
Lot # 22140903. Exp. Dec. 2024
Where it was sold
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
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0159-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 28, 2022
- FDA report date
- Jan 25, 2023
- Quantity
- 12192 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-0159-2023, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91385
- Address
- 339 Jefferson Rd Ste 101
- Code information
- Lot # 22140903. Exp. Dec. 2024
- Postal code
- 07054-3707
- Report date
- Jan 25, 2023
- Product type
- Drugs
- Recall number
- D-0159-2023
- Classification
- Class II
- Recalling firm
- Ascend Laboratories, LLC
- Product quantity
- 12192 bottles
- Termination date
- Aug 15, 2024
- Reason for recall
- Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- 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
- Recall initiation date
- Dec 28, 2022
- Initial firm notification
- Center classification date
- Jan 16, 2023