Home / Recalls / Advanced Pharma Inc. / D-1023-2019

D-1023-2019 Class II Terminated

Recalled by Advanced Pharma Inc. — Houston, TX

Recall Details

Product Type
Drugs
Report Date
March 27, 2019
Initiation Date
March 13, 2019
Termination Date
January 14, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22900 syringes

Product Description

Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide

Code Information

Lots: 10/24/18 3318 83061S Exp. 3/23/2019; 10/18/18 3354 83061S Exp. 3/17/2019; 10/23/2018 6050 83061S Exp. 3/22/2019; 10/23/18 8105 83061S Exp. 3/22/2019; 10/18/18 1961 83061S Exp. 3/17/2019; 10/18/18 2598 83061S Exp. 3/17/2019; 11/05/18 1184 83061S Exp. 4/4/2019; 10/22/18 0737 83061S Exp. 3/21/2019; 10/25/18 1198 83061S Exp. 3/24/2019; 11/06/18 4451 83061S Exp. 4/5/2019; 11/06/18 0108 83061S Exp. 4/5/2019; 10/22/18 1530 83061S Exp. 3/21/2019

Other recalls by Advanced Pharma Inc.

  • D-1251-2019 Class II — HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sod (April 26, 2019)
  • D-1018-2019 Class II — fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, (March 13, 2019)
  • D-1031-2019 Class II — Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in (March 13, 2019)
  • D-1030-2019 Class II — Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable S (March 13, 2019)
  • D-1016-2019 Class II — HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg (March 13, 2019)
  • D-1019-2019 Class II — Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HC (March 13, 2019)
  • D-1032-2019 Class II — Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solu (March 13, 2019)
  • D-1028-2019 Class II — Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution (March 13, 2019)
  • D-1017-2019 Class II — fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, (March 13, 2019)
  • D-1025-2019 Class II — Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile sin (March 13, 2019)