Cardinal Health Recalls Medroxyprogesterone Acetate Syringes Due to Temperature Excursions
Cardinal Health is recalling 286 prefilled syringes of medroxyprogesterone acetate due to intermittent temperature excursions during storage.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 286 prefilled syringes of medroxyprogesterone acetate injectable suspension, USP 150 mg per mL. The product is distributed by Greenstone, LLC, and carries the NDC 59762-4538-2. The specific lot code for the recalled units is EC4744.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. This issue may affect the stability or quality of the medication.
The affected syringes were distributed in Florida, Georgia, and South Carolina. Healthcare providers and patients should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions.
The recalled product
- Product
- Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefilled Syringe Rx only NDC 59762-4538-2 Distributed by: Greenstone, LLC. Peapack, NJ 07977
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Injectable Steroid
- Affected units
- 286
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- EC4744
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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