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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot# 20142104@30 USE BY: 10/18/2014
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1548-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 16, 2014
- FDA report date
- Aug 27, 2014
- Quantity
- 762 Syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- US Compounding Inc
Original FDA data
Every field from FDA enforcement report D-1548-2014, exactly as published.
Show all FDA fields
- City
- Conway
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 68336
- Address
- 1270 Don's Lane
- Code information
- Lot# 20142104@30 USE BY: 10/18/2014
- Postal code
- 72032
- Report date
- Aug 27, 2014
- Product type
- Drugs
- Recall number
- D-1548-2014
- Classification
- Class II
- Recalling firm
- US Compounding Inc
- Product quantity
- 762 Syringes
- Termination date
- Nov 4, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- May 16, 2014
- Initial firm notification
- Telephone
- Center classification date
- Aug 20, 2014