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D-0821-2017 Class II Terminated

Recalled by Advanced Pharma Inc. — Houston, TX

FDA drug recall D-0821-2017 was initiated by Advanced Pharma Inc. on February 22, 2017 and is designated Class II. Reason for recall: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. The recall status is terminated (terminated October 18, 2017).

Recall Details

Product Type
Drugs
Report Date
May 31, 2017
Initiation Date
February 22, 2017
Termination Date
October 18, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Reason for Recall

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Distribution Pattern

U.S. Nationwide

Code Information

all lots within expiry

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