Why it was recalled
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
Product description
Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01.
Lot numbers, UPCs & expiration codes
Lot #: 18038, 18039, Exp 03/2023; 18079, Exp 05/2023
Where it was sold
Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.
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-0008-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 9, 2021
- FDA report date
- Oct 6, 2021
- Quantity
- 2,324 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jacobus Pharmaceutical Company Inc.
Original FDA data
Every field from FDA enforcement report D-0008-2022, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88647
- Address
- Industrial Research Laboratory Building
- Address (line 2)
- 31 Schalks Crossing Rd
- Code information
- Lot #: 18038, 18039, Exp 03/2023; 18079, Exp 05/2023
- Postal code
- 08536
- Report date
- Oct 6, 2021
- Product type
- Drugs
- Recall number
- D-0008-2022
- Classification
- Class I
- Recalling firm
- Jacobus Pharmaceutical Company Inc.
- Product quantity
- 2,324 bottles
- Termination date
- Feb 18, 2022
- Reason for recall
- Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01.
- Distribution pattern
- Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.
- Recall initiation date
- Sep 9, 2021
- Initial firm notification
- Letter
- Center classification date
- Oct 8, 2021