Drug product
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.
D-0015-2019
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 81126
- Status
- Terminated
- Classification
- Class II
- Quantity
- 94,752 bags
- Official record key
drug-enforcement:D-0015-2019
Official wording
Reason: 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.
Code information: Lot: 87904FW, Exp. 1MAR2020
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Unknown
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.