Recalls / Class II
Class IID-0810-2017
Product
Hydromorphone HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Affected lot / code info
- all lots
Why it was recalled
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recalling firm
- Firm
- Advanced Pharma Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 9265 Kirby Dr, Houston, Texas 77054-2520
Distribution
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2017-02-22
- FDA classified
- 2017-05-23
- Posted by FDA
- 2017-05-31
- Terminated
- 2017-10-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0810-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.