Recalls / Class II
Class IID-1548-2014
Product
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
- Affected lot / code info
- Lot# 20142104@30 USE BY: 10/18/2014
Why it was recalled
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.
Recalling firm
- Firm
- US Compounding Inc
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 1270 Don's Lane, Conway, Arkansas 72032
Distribution
- Quantity
- 762 Syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-05-16
- FDA classified
- 2014-08-20
- Posted by FDA
- 2014-08-27
- Terminated
- 2014-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1548-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.