FDA Recall D-1830-2015
Hartley Medical Center Pharmacy, Incorporated · Long Beach, CA
Class I — life-threatening Terminated 135 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888
Reason for recall
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Recall record
- Recall number
D-1830-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- CA and NV
- Recall initiated
- 2015-08-17
- Classified by FDA Center
- 2015-09-25
- FDA published
- 2015-10-07
- Terminated
- 2015-12-30
- Recalling firm
- Hartley Medical Center Pharmacy, Incorporated
- Firm location
- Long Beach, CA