Why it was recalled
Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead.
Product description
CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by Medisca Inc. Plattsburgh, NY 12901, USA, NDC #s: 38779-1186-4 (25 g), 38779-1186-5 (100 g), 38779-1186-8 (500 g), 38779-1186-9 (1 kg).
Lot numbers, UPCs & expiration codes
Lot #s: 95482/A, 95482/B, 95482/C, 95482/D, 96453/A, 96453/B, 96453/C, and 96453/D, Exp. 10/31/2014
Where it was sold
Nationwide and Australia
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-0674-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 14, 2014
- FDA report date
- Feb 24, 2016
- Quantity
- 25 g: 15 bottles, 100 g: 153 bottles; 500 g: 18 bottles, 1 kg: 24 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medisca Inc
Original FDA data
Every field from FDA enforcement report D-0674-2016, exactly as published.
Show all FDA fields
- City
- Plattsburgh
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 67531
- Address
- 661 State Route 3
- Address (line 2)
- Unit C
- Code information
- Lot #s: 95482/A, 95482/B, 95482/C, 95482/D, 96453/A, 96453/B, 96453/C, and 96453/D, Exp. 10/31/2014
- Postal code
- 12901-6531
- Report date
- Feb 24, 2016
- Product type
- Drugs
- Recall number
- D-0674-2016
- Classification
- Class I
- Recalling firm
- Medisca Inc
- Product quantity
- 25 g: 15 bottles, 100 g: 153 bottles; 500 g: 18 bottles, 1 kg: 24 bottles
- Termination date
- Feb 17, 2016
- Reason for recall
- Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by Medisca Inc. Plattsburgh, NY 12901, USA, NDC #s: 38779-1186-4 (25 g), 38779-1186-5 (100 g), 38779-1186-8 (500 g), 38779-1186-9 (1 kg).
- Distribution pattern
- Nationwide and Australia
- Recall initiation date
- Feb 14, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Feb 17, 2016