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D-0497-2019 Class III Terminated

Recalled by Advanced Pharma Inc. — Houston, TX

FDA drug recall D-0497-2019 was initiated by Advanced Pharma Inc. on February 6, 2019 and is designated Class III. Reason for recall: Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. The recall status is terminated (terminated October 30, 2019). Affected quantity: 12 bags.

Recall Details

Product Type
Drugs
Report Date
February 27, 2019
Initiation Date
February 6, 2019
Termination Date
October 30, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 bags

Product Description

Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.

Reason for Recall

Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

Distribution Pattern

Nationwide in the USA.

Code Information

Lot: 12/20/18 1056 73099P, BUD: 02/03/2019

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-1024-2019 Class II — Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile (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-1021-2019 Class II — Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use (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-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-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-1029-2019 Class II — Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single u (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)

FDA data resources