D-0015-2019 Class II Terminated
FDA drug recall D-0015-2019 was initiated by Pfizer Inc. on Oct 3, 2018 and is designated Class II. 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… The recall status is terminated (terminated Oct 2, 2020). Affected quantity: 94,752 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 17, 2018
- Initiation Date
- Oct 3, 2018
- Termination Date
- Oct 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 94,752 bags
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.
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot: 87904FW, Exp. 1MAR2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0015-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026