FDA Recall D-0251-2015
Abrams Royal Pharmacy · Dallas, TX
Class I — life-threatening Terminated 1267 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX
Reason for recall
Non-Sterility
Recall record
- Recall number
D-0251-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Texas
- Recall initiated
- 2013-04-19
- Classified by FDA Center
- 2014-11-17
- FDA published
- 2014-11-26
- Terminated
- 2016-10-07
- Recalling firm
- Abrams Royal Pharmacy
- Firm location
- Dallas, TX