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D-0430-2019 Class II Terminated

Recalled by Advanced Pharma Inc. — Houston, TX

FDA drug recall D-0430-2019 was initiated by Advanced Pharma Inc. on January 15, 2019 and is designated Class II. Reason for recall: Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL) The recall status is terminated (terminated May 1, 2019). Affected quantity: 160 syringes.

Recall Details

Product Type
Drugs
Report Date
January 30, 2019
Initiation Date
January 15, 2019
Termination Date
May 1, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
160 syringes

Product Description

HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syringe, Avella of Houston an FDA Registered 503B Outsourcing Facility 9265 Kirby Dr. Houston, TX 77054 (877) 794-0404 ---- NDC: 42852-725-65

Reason for Recall

Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)

Distribution Pattern

TX, WA

Code Information

Lot: 12/19/18 0242 72565S BUD: 3/31/19

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-1031-2019 Class II — Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in (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-1025-2019 Class II — Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile sin (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-1027-2019 Class II — 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile si (March 13, 2019)
  • D-1024-2019 Class II — Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile (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)
  • D-1021-2019 Class II — Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use (March 13, 2019)

FDA data resources