Home / Recalls / Guardian Pharmacy Services / D-1071-2018

D-1071-2018 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
2000 100-ml vials

Product Description

Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. 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: 58409:42, Use By: 05/21/2018; 58899:42, Use By: 07/04/2018; 59215:42 Use By: 08/01/2018

Other recalls by Guardian Pharmacy Services

  • D-1051-2018 Class II — Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compoun (May 17, 2018)
  • D-1064-2018 Class II — Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Gua (May 17, 2018)
  • 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)