Recalls / Class II
Class IID-0939-2018
Product
NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-815-25
- Affected lot / code info
- Lot #4/23/18 0101 81525P, 4/23/18 1020 81525P, BUD 6/22/2018;4/30/18 1123 81525P, 4/30/18 1311 81525P, BUD 6/29/2018; 5/1/18 3456 81525P, BUD 6/30/2018; 5/8/18 3213 81525P, BUD 7/7/2018.
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
- 4,280 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-0939-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.