Home / Recalls / Synergy Rx / D-0593-2017

D-0593-2017 Class II Terminated

Recalled by Synergy Rx — San Diego, CA

Recall Details

Product Type
Drugs
Report Date
March 22, 2017
Initiation Date
February 10, 2017
Termination Date
May 23, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% CREAM, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% OINTMENT LIDOCAINE 23%/ TETRACAINE 7% CREAM, LIDOCAINE 23%/TETRACAINE 7% OINTMENT, LIDOCAINE 23%/TETRACAINE 7%/PRILOCAONE 2.5%, LIDOCAINE 24%/PRILOCAINE 26% OINTMENT, LIDOCAINE 30%/TETRACAINE 4% /PRILOCAINE 2%, LIDOCAINE 30%/PHENYLEPHRINE 0.25%, LIDOCAINE 30%/ TETRACAINE 10%, MELYLEPHRINE 4%, LIDOCAINE 30%/TETRACAINE 4%/PRILOCAINE, LIDOCAINE 7%/TETRACAINE 7% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Reason for Recall

Lack of Assurance of Sterility: There are also CGMP Deviations.

Distribution Pattern

Nationwide within the United States

Code Information

All Lots

Other recalls by Synergy Rx

  • D-0528-2017 Class II — MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.025 (February 10, 2017)
  • D-0559-2017 Class II — GENTLE BLEACHING CREAM (Retinoic Acid 0.025, Kojic Acid 3%,Hydrocortisone 1%), R (February 10, 2017)
  • D-0592-2017 Class II — RETIN-A 0.05% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA (February 10, 2017)
  • D-0537-2017 Class II — FLUORORACIL 0.05% CREAM, FLUORORACIL 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM (February 10, 2017)
  • D-0585-2017 Class II — HUMAN CHORIONIC GONADOTROPIN in 300IU and 500 IU TABLETS, Rx only, Synergy RX, 4 (February 10, 2017)
  • D-0526-2017 Class II — TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%, Rx only, Synergy R (February 10, 2017)
  • D-0546-2017 Class II — VITAMIN K OXIDE 5%, HQ 4%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Die (February 10, 2017)
  • D-0566-2017 Class II — MODIFIED JESSNER PEEL (Sal Acid 14%, Lactic Acid 14%, glycolic 14%), Rx only, Sy (February 10, 2017)
  • D-0530-2017 Class II — ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2,5% (February 10, 2017)
  • D-0544-2017 Class II — TRICHLOROACETIC ACID SOLUTION in all strengths including: 10%, 12%, 15 %, 20%, (February 10, 2017)