Why it was recalled
Labeling: Missing label
Product description
CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, NDC 63323-311-10
Lot numbers, UPCs & expiration codes
Lot 6004889, Expiration Date 10/2014
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-200-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 1, 2013
- FDA report date
- Mar 20, 2013
- Quantity
- 155,900 vials domestically
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA LLC (FK USA)
Original FDA data
Every field from FDA enforcement report D-200-2013, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 64266
- Address
- 1501 E Woodfield Rd
- Address (line 2)
- Suite 300 East
- Code information
- Lot 6004889, Expiration Date 10/2014
- Postal code
- 60173-6052
- Report date
- Mar 20, 2013
- Product type
- Drugs
- Recall number
- D-200-2013
- Classification
- Class III
- Recalling firm
- Fresenius Kabi USA LLC (FK USA)
- Product quantity
- 155,900 vials domestically
- Termination date
- Nov 18, 2013
- Reason for recall
- Labeling: Missing label
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, NDC 63323-311-10
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 1, 2013
- Initial firm notification
- Letter
- Center classification date
- Mar 13, 2013