Recalls / Class II
Class IID-1033-2019
Product
Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL Sterile singe use syringe, NDC: 42852-241-63 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Affected lot / code info
- Lots: 10/19/18 2117 24163M Exp. 3/18/2019; 11/5/18 1363 24163M Exp. 4/4/2019; 11/5/18 1511 24163M Exp. 4/4/2019; 10/19/18 2061 24163M Exp. 3/18/2019; 10/23/18 1963 14163M Exp. 3/22/2019; 10/19/18 1441 24163M Exp. 3/18/2019
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Advanced Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9265 Kirby Dr, N/A, Houston, Texas 77054-2520
Distribution
- Quantity
- 2325 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-03-13
- FDA classified
- 2019-03-21
- Posted by FDA
- 2019-03-27
- Terminated
- 2020-01-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1033-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.