Home / Recalls / Auro Pharmacies, Inc. / D-1159-2018

D-1159-2018 Class II Terminated

Recalled by Auro Pharmacies, Inc. — La Habra, CA

FDA drug recall D-1159-2018 was initiated by Auro Pharmacies, Inc. on August 21, 2018 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. The recall status is terminated (terminated January 30, 2020). Affected quantity: 183 vials.

Recall Details

Product Type
Drugs
Report Date
September 5, 2018
Initiation Date
August 21, 2018
Termination Date
January 30, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
183 vials

Product Description

Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

Reason for Recall

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Distribution Pattern

Nationwide in USA

Code Information

Lot #: 180716/21, Exp 14-Oct-18

Other recalls by Auro Pharmacies, Inc.

  • D-1158-2018 Class II — Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Dru (August 21, 2018)
  • D-1157-2018 Class II — Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drug (August 21, 2018)
  • D-1161-2018 Class II — Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Central (August 21, 2018)
  • D-1165-2018 Class II — Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL a (August 21, 2018)
  • D-1162-2018 Class II — Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Centra (August 21, 2018)
  • D-1164-2018 Class II — Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL a (August 21, 2018)
  • D-1163-2018 Class II — Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL a (August 21, 2018)
  • D-1160-2018 Class II — Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple (August 21, 2018)
  • D-1156-2018 Class II — CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central Dr (August 21, 2018)
  • D-1167-2018 Class II — Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Centra (August 21, 2018)

FDA data resources