Recalls / Class II
Class IID-1133-2015
Product
PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR (877) 550-5059, barcode 88888772029.
- Affected lot / code info
- Lot: 20150423@47, Exp 07/22/15
Why it was recalled
Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 8821 Knoedl Ct, N/A, Little Rock, Arkansas 72205-4600
Distribution
- Quantity
- 50 bags
- Distribution pattern
- CA
Timeline
- Recall initiated
- 2015-04-28
- FDA classified
- 2015-06-10
- Posted by FDA
- 2015-06-17
- Terminated
- 2016-12-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1133-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.