Why it was recalled
Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.
Product description
Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111, USA; Wallcur Practi Products for Clinical Simulation; NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, 5108-0954-73.
Lot numbers, UPCs & expiration codes
No unique lot number on product; all Practi-0.9% Sodium Chloride is subject to recall.
Where it was sold
United States including Puerto Rico; and Canada
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-0434-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 6, 2015
- FDA report date
- Apr 15, 2015
- Quantity
- 18,657 Bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wallcur Incorporated
Original FDA data
Every field from FDA enforcement report D-0434-2015, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 70155
- Address
- 7190 Clairemont Mesa Blvd
- Code information
- No unique lot number on product; all Practi-0.9% Sodium Chloride is subject to recall.
- Postal code
- 92111-1005
- Report date
- Apr 15, 2015
- Product type
- Drugs
- Recall number
- D-0434-2015
- Classification
- Class I
- Recalling firm
- Wallcur Incorporated
- Product quantity
- 18,657 Bags
- Termination date
- Nov 25, 2015
- Reason for recall
- Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111, USA; Wallcur Practi Products for Clinical Simulation; NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, 5108-0954-73.
- Distribution pattern
- United States including Puerto Rico; and Canada
- Recall initiation date
- Jan 6, 2015
- Initial firm notification
- Center classification date
- Apr 6, 2015