Why it was recalled
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Product description
8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
Lot numbers, UPCs & expiration codes
Lot # 56-148-EV, Exp 8/1/2017
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-0865-2016
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Mar 18, 2016
- FDA report date
- Jun 1, 2016
- Quantity
- 72,000 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0865-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 73653
- Address
- 275 N Field Dr
- Code information
- Lot # 56-148-EV, Exp 8/1/2017
- Postal code
- 60045-2579
- Report date
- Jun 1, 2016
- Product type
- Drugs
- Recall number
- D-0865-2016
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 72,000 units
- Reason for recall
- Presence of Particulate Matter: particulate matter identified as an insect in one vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 18, 2016
- Initial firm notification
- Letter
- Center classification date
- May 23, 2016