Why it was recalled
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Product description
MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32.
Lot numbers, UPCs & expiration codes
Lot: 20170710@54, BUD: 10/8/2017
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-1003-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 14, 2017
- FDA report date
- Aug 2, 2017
- Quantity
- 40 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1003-2017, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 77777
- Address
- 8821 Knoedl Ct
- Code information
- Lot: 20170710@54, BUD: 10/8/2017
- Postal code
- 72205-4600
- Report date
- Aug 2, 2017
- Product type
- Drugs
- Recall number
- D-1003-2017
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 40 bags
- Termination date
- Oct 30, 2019
- Reason for recall
- Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 14, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 25, 2017