Why it was recalled
Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.
Product description
Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-6729-03.
Lot numbers, UPCs & expiration codes
Lot: 87904FW, Exp. 1MAR2020
Where it was sold
Nationwide in the USA and Puerto Rico
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-0015-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 3, 2018
- FDA report date
- Oct 17, 2018
- Quantity
- 94,752 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0015-2019, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 81126
- Address
- 235 E 42nd St
- Code information
- Lot: 87904FW, Exp. 1MAR2020
- Postal code
- 10017-5703
- Report date
- Oct 17, 2018
- Product type
- Drugs
- Recall number
- D-0015-2019
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 94,752 bags
- Termination date
- Oct 2, 2020
- Reason for recall
- Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-6729-03.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Oct 3, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 11, 2018