Oxytocic
Where is Oxytocin made?
6 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 4 factories in the United States, Portugal and India.
United States 2Portugal 1India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC10 [USP'U] per 1 mL · NDC 65219-021 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 | |
| Fresenius Kabi, LLC10 [USP'U] per 1 mL · NDC 63323-012 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 | |
| Hikma Pharmaceuticals USA Inc.10 [USP'U] per 1 mL · NDC 0143-9743, 0143-9742 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Hikma Pharmaceuticals USA Inc.10 [USP'U] per 1 mL · NDC 0641-6114, 0641-6115 | Gland Pharma LimitedMakes it, tests it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Cantrell Drug Company2 [USP'U] per 100 mL, 10 [USP'U] per 1000 mL, 20 [USP'U] per 500 mL, 30 [USP'U] per 1000 mL, 30 [USP'U] per 500 mL · NDC 52533-048, 52533-105, 52533-051 +6 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc. Pitocin10 [iU] per 1 mL · NDC 42023-116, 42023-130 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Oxytocin in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Cardinal Health 107, LLC:
55154-9584 - Remedyrepack Inc.:
70518-4233
Recalls
- Nov 18, 2016 · Class II · Cantrell Drug Company
Lack of Assurance of Sterility - the firm is recalling select sterile drug products. - Jun 24, 2013 · Class II · Fresenius Kabi USA, LLC
Subpotent Drug; 15-month stability test station - Jun 5, 2012 · Class III · JHP Pharmaceuticals, LLC
Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.