Hospira Recalls Magnesium Sulfate Injection Due to pH Failures
Hospira Inc. is recalling 715,200 vials of Magnesium Sulfate Injection, USP 50% due to confirmed high out-of-specification pH results.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as unlikely to cause adverse health consequences, typically resulting in a score of 1 or 2.
Plain-English summary
Hospira Inc. is recalling 715,200 vials of Magnesium Sulfate Injection, USP 50%, 10 g/20 mL. The product is packaged in 25-vial boxes and is available by prescription only. The recall is being conducted because of confirmed high out-of-specification (OOS) results for pH.
The affected lots include 42-335-DK (Exp 1JUN2016); 48-128-DK, 48-129-DK, 48-261-DK, 48-262-DK, and 48-351-DK (Exp 1DEC2016); and 52-361-DK (Exp 1APR2017). Note that lot numbers may be followed by numbers from 01 to 99. The product was distributed nationwide, as well as in Puerto Rico, the United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago.
The FDA has classified this as a Class III recall. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above and stop using the product if it matches the recalled description.
The recalled product
- Product
- Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 715,200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot #: 42-335-DK
- Exp 1JUN2016
- 48-128-DK
- 48-129-DK
- 48-261-DK
- 48-262-DK
- 48-351-DK
- Exp 1DEC2016
- 52-361-DK
- Exp 1APR2017
- note that the lot number may be followed by numbers from 01 to 99.
Distribution
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