Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Product description
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12
Lot numbers, UPCs & expiration codes
Lot#: 20171013@30, Exp 12/27/2017
Where it was sold
U.S.A. 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-0156-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 7, 2017
- FDA report date
- Jan 17, 2018
- Quantity
- 1248 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0156-2018, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 78708
- Address
- 8821 Knoedl Ct
- Code information
- Lot#: 20171013@30, Exp 12/27/2017
- Postal code
- 72205-4600
- Report date
- Jan 17, 2018
- Product type
- Drugs
- Recall number
- D-0156-2018
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 1248 syringes
- Termination date
- May 1, 2019
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Dec 7, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 5, 2018