Class II
Terminated
ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/Hospital Use Only, Protect from Light, 62295-3084-05, US Compounding Pharmacy, Conway, AR 800-718-3588
This recall has been terminated (originally issued August 27, 2014).
- Company
- Us Compounding Inc
- Recall Initiated
- May 16, 2014
- Posted
- August 27, 2014
- Recall Number
- D-1548-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 762 Syringes
- Firm Location
- Conway, AR, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL in small font, however, the actual syringes were correctly labeled as 25 mg/5 mL.
Distribution
Nationwide
Lot / Code Info
Lot# 20142104@30 USE BY: 10/18/2014
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