FDA Drug Recalls

Recalls / Class II

Class IID-0954-2018

Product

MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-243-63

Affected lot / code info
Lot #:2/26/18 2233 24363M, BUD 6/26/2018.

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
740 syringes
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-0954-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.