Home / Recalls / Advanced Pharma Inc. / D-0889-2018

D-0889-2018 Class II Terminated

Recalled by Advanced Pharma Inc. — Houston, TX

Recall Details

Product Type
Drugs
Report Date
July 4, 2018
Initiation Date
June 20, 2018
Termination Date
April 3, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
100 syringes

Product Description

fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.

Reason for Recall

Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.

Distribution Pattern

Distributed to one medical center in Fort Worth, TX.

Code Information

Lot #: 6/12/18 0432 149-21072S, BUD 9/10/18

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-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-1031-2019 Class II — Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in (March 13, 2019)
  • D-1026-2019 Class II — 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile sin (March 13, 2019)
  • D-1021-2019 Class II — Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use (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-1027-2019 Class II — 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile si (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-1029-2019 Class II — Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single u (March 13, 2019)