Home / Recalls / Guardian Pharmacy Services / D-1064-2018

D-1064-2018 Class II Terminated

Recalled by Guardian Pharmacy Services — Dallas, TX

Recall Details

Product Type
Drugs
Report Date
August 15, 2018
Initiation Date
May 17, 2018
Termination Date
November 25, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20 400-ml ON-Q Pump

Product Description

Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Reason for Recall

Lack of sterility assurance.

Distribution Pattern

Texas

Code Information

Lots: 59088:42 Use By: 05/24/2018; 59159:42 Use By: 05/30/2018

Other recalls by Guardian Pharmacy Services

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  • D-1060-2018 Class II — Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. Comp (May 17, 2018)
  • D-1052-2018 Class II — Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compoun (May 17, 2018)
  • D-1065-2018 Class II — Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Gua (May 17, 2018)
  • D-1066-2018 Class II — Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Gua (May 17, 2018)
  • D-1069-2018 Class II — Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pha (May 17, 2018)
  • D-1072-2018 Class II — MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guardian (May 17, 2018)
  • D-1058-2018 Class II — Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guar (May 17, 2018)
  • D-1055-2018 Class II — EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compoun (May 17, 2018)
  • D-1068-2018 Class II — Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded Gu (May 17, 2018)