Why it was recalled
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Product description
Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-626-90
Lot numbers, UPCs & expiration codes
23140190, Exp. Date 12/31/2024
Where it was sold
Nationwide
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-0237-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 29, 2023
- FDA report date
- Jan 24, 2024
- Quantity
- 3,288 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-0237-2024, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 93701
- Address
- 339 Jefferson Rd Ste 101
- Code information
- 23140190, Exp. Date 12/31/2024
- Postal code
- 07054-3707
- Report date
- Jan 24, 2024
- Product type
- Drugs
- Recall number
- D-0237-2024
- Classification
- Class II
- Recalling firm
- Ascend Laboratories, LLC
- Product quantity
- 3,288 bottles
- Reason for recall
- Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-626-90
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 29, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 17, 2024