Recalls / Class II
Class IID-0931-2018
Product
EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-855-25.
- Affected lot / code info
- Lot # 5/4/18 0300 58-85525P, BUD 6/18/2018; 5/10/18 1435 262-85525P, 5/10/18 1127 558-85525P, BUD 6/24/2018; 5/11/18 1327 457-85525P, BUD 6/25/2018; 5/14/18 0302 295-85525P, BUD 6/28/2018; 5/17/18 0500 558-85525P, BUD 7/1/2018; 5/24/18 1005 57-85525P, 5/24/18 1328 295-85525P, BUD 7/7/2018; 5/25/18 0302 295-85525P, BUD 7/9/2018; 5/30/18 0936 262-85525P, BUD 7/14/2018; 5/31/18 0805 558-85525P, BUD 7/17/2018.
Why it was recalled
Lack of Assurance of Sterility: Potential leakage of bags.
Recalling firm
- Firm
- Avella of Deer Valley, Inc. Store 38
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 24416 N 19th Ave, Phoenix, Arizona 85085-1887
Distribution
- Quantity
- 420 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-06-12
- FDA classified
- 2018-07-19
- Posted by FDA
- 2018-07-25
- Terminated
- 2020-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0931-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.