FDA Recalls 17-0H Progesterone Vials Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling 17-0H Progesterone vials because FDA inspections found GMP violations that may affect sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a parenteral product, which poses a significant risk of serious injury or infection.
Plain-English summary
Well Care Compounding Pharmacy is recalling 17-0H Progesterone 250mg/mL, packaged in 5mL vials, due to a lack of assurance of sterility. The recall involves 869 units distributed in Nevada.
The U.S. Food and Drug Administration (FDA) identified Good Manufacturing Practice (GMP) violations during an inspection that potentially impact the product's quality and sterility. The affected lots include 04262016, 03102016, 12222015, and 02022016.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- 17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Hazard
- Affected units
- 869
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 (8)
- Lot #: 04262016: 87@3
- Exp. 07/26/2016
- Lot #: 03102016:72@38
- Exp. 06/08/2016
- Lot #: 12222015:88@23
- Exp. 03/22/2016
- Lot #: 02022016:73@27
- Exp. 05/03/2016
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Well Care Compounding Pharmacy 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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