Why it was recalled
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Product description
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02
Lot numbers, UPCs & expiration codes
G105197, Exp. 02/14
Where it was sold
Nationwide, Saudi Arabia and Colombia
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-1057-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 18, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 49,932 glass containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-1057-2014, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 66880
- Address
- 1 Baxter Pkwy
- Code information
- G105197, Exp. 02/14
- Postal code
- 60015-4625
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1057-2014
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 49,932 glass containers
- Termination date
- Sep 15, 2014
- Reason for recall
- Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02
- Distribution pattern
- Nationwide, Saudi Arabia and Colombia
- Recall initiation date
- Nov 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 31, 2014