Drug 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.
D-0854-2016
Product summary
- Firm
- Hospira Inc.
- Event
- Event 73681
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 715,200 vials
- Official record key
drug-enforcement:D-0854-2016
Official wording
Reason: Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Code information: 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 pattern: Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago
Derived failure modes
-
Potency or specification failure
out of specification