Recalls / Class II
Class IID-0156-2018
Product
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
- Affected lot / code info
- Lot#: 20171013@30, Exp 12/27/2017
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8821 Knoedl Ct, N/A, Little Rock, Arkansas 72205-4600
Distribution
- Quantity
- 1248 syringes
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2017-12-07
- FDA classified
- 2018-01-05
- Posted by FDA
- 2018-01-17
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0156-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.