Recalls / Class II
Class IID-0015-2019
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.
- Brand name
- Magnesium Sulfate In Water
- Generic name
- Magnesium Sulfate In Water
- Active ingredient
- Magnesium Sulfate Heptahydrate
- Route
- Intravenous
- NDCs
- 0409-2050, 0409-6730, 0409-6729, 0409-4121, 0409-3164, 0409-5239
- FDA application
- NDA020309
- Affected lot / code info
- Lot: 87904FW, Exp. 1MAR2020
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.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, New York, New York 10017-5703
Distribution
- Quantity
- 94,752 bags
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2018-10-03
- FDA classified
- 2018-10-11
- Posted by FDA
- 2018-10-17
- Terminated
- 2020-10-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0015-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.