Why it was recalled
Lack of assurance of sterility: Product bags leaking at seam.
Product description
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32
Lot numbers, UPCs & expiration codes
LOT # 20170509@29, Use By: 08/07/17
Where it was sold
Nationwide in the USA
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-0878-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 18, 2017
- FDA report date
- Jun 7, 2017
- Quantity
- 40 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0878-2017, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 77314
- Address
- 8821 Knoedl Ct
- Code information
- LOT # 20170509@29, Use By: 08/07/17
- Postal code
- 72205-4600
- Report date
- Jun 7, 2017
- Product type
- Drugs
- Recall number
- D-0878-2017
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 40 bags
- Termination date
- Mar 29, 2018
- Reason for recall
- Lack of assurance of sterility: Product bags leaking at seam.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 18, 2017
- Initial firm notification
- Letter
- Center classification date
- May 31, 2017