Recalls / Class II
Class IID-1012-2015
Product
Testosterone 100 mg/1 mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Affected lot / code info
- All lots
Why it was recalled
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Recalling firm
- Firm
- Health Innovations Pharmacy, Inc
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 295 Pinehurst Ave Bldg 2, N/A, Southern Pines, North Carolina 28387-7051
Distribution
- Quantity
- N/A
- Distribution pattern
- NC
Timeline
- Recall initiated
- 2015-02-12
- FDA classified
- 2015-05-08
- Posted by FDA
- 2015-05-20
- Terminated
- 2017-07-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1012-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.