FDA Recalls Hydroxyprogesterone Caproate Injectable Due to Compounding Conditions
Professional Compounding Pharmacy is recalling Hydroxyprogesterone Caproate 250 mg/mL injectable because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterile injectable) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Hydroxyprogesterone Caproate 250 mg/mL Oil Injectable, manufactured by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy in Corvallis, Oregon. The recall covers 4 prescriptions of 9 ml and 10 ml injectables.
The recall was initiated because FDA inspectors observed insanitary conditions during the compounding of sterile drugs during a recent inspection. The specific lots affected are 01112018@19, 04012019@52, 14022019@23, and 14012019@36, which were distributed between September 1, 2018, and February 20, 2019.
These products were dispensed in Oregon. Patients who have received this medication should contact their healthcare provider or the pharmacy for further instructions on how to proceed.
The recalled product
- Product
- HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml injectable, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
- Category
- Drug — Injectable
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 (5)
- Lots: (a) 01112018@19
- 04012019@52
- 14022019@23
- (b) 14012019@36
- distributed between 09-01-2018 to 02-20-2019.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 25 recalled by Health Solutions Pharmacy Center Inc dba Professional 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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