FDA Recall D-0228-2017
Town and Country Compounding and Consultation Services · Ridgewood, NJ
Class I — life-threatening Terminated 1163 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502
Reason for recall
Non-Sterility; microbial contamination identified as Bacillus circulans
Recall record
- Recall number
D-0228-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- MA, NY, NJ & FL; Canada
- Recall initiated
- 2016-08-01
- Classified by FDA Center
- 2016-12-22
- FDA published
- 2016-12-28
- Terminated
- 2019-10-08
- Recalling firm
- Town and Country Compounding and Consultation Services
- Firm location
- Ridgewood, NJ