Recalls / Class II
Class IID-0136-2019
Product
Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- NDC 69699-1424-10
- Affected lot / code info
- Lots: 07032018:93 Discard by: 01/03/2019; 07032018:27 Discard by: 01/03/2019; 07032018:97 Discard by: 01/03/2019
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Pharm D Solutions, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1304 S Loop W, N/A, Houston, Texas 77054-4010
Distribution
- Quantity
- 486 milliliters
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-09-10
- FDA classified
- 2018-11-01
- Posted by FDA
- 2018-11-07
- Terminated
- 2021-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0136-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.