Recalls / Class II
Class IID-0911-2016
Product
0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
- Affected lot / code info
- All product remaining within expiry
Why it was recalled
Lack of Sterility Assurance
Recalling firm
- Firm
- Baptist Health Medical Towers Pharmacy and Infusion Services
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 9601 Baptist Health Dr Ste 109, N/A, Little Rock, Arkansas 72205-6323
Distribution
- Quantity
- a) 6 bags b) 1 bag c) 2 bags
- Distribution pattern
- Arkansas
Timeline
- Recall initiated
- 2016-04-18
- FDA classified
- 2016-05-29
- Posted by FDA
- 2016-06-08
- Terminated
- 2016-12-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0911-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.