FDA Recall D-1052-2014
NuVision Pharmacy, Inc. · Dallas, TX
Class I — life-threatening Terminated 1395 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244
Reason for recall
Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
Recall record
- Recall number
D-1052-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2013-04-15
- Classified by FDA Center
- 2014-01-30
- FDA published
- 2014-02-05
- Terminated
- 2017-02-08
- Recalling firm
- NuVision Pharmacy, Inc.
- Firm location
- Dallas, TX