Why it was recalled
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
Product description
Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50
Lot numbers, UPCs & expiration codes
Lot #: 6103882, Exp 10/14
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-920-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 25, 2013
- FDA report date
- Sep 4, 2013
- Quantity
- 15,625 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-920-2013, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 65218
- Address
- 3 Corporate Dr
- Code information
- Lot #: 6103882, Exp 10/14
- Postal code
- 60047-8930
- Report date
- Sep 4, 2013
- Product type
- Drugs
- Recall number
- D-920-2013
- Classification
- Class I
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 15,625 vials
- Termination date
- Mar 10, 2016
- Reason for recall
- Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50
- Distribution pattern
- Nationwide
- Recall initiation date
- May 25, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 23, 2013