Dexamethasone Eye Drops Recalled Due to Insanitary Compounding Conditions
Professional Compounding Pharmacy is recalling 12 prescriptions of Dexamethasone eye drops due to insanitary conditions observed during compounding.
What this means for you
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 eye drops) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy is recalling 12 prescriptions of Dexamethasone (NAPO4) 0.1% Ophth* Pres-Free Solution, 10ml, Eye Drops. The recall was initiated because insanitary conditions were observed during the compounding of sterile drugs during a recent FDA inspection.
The affected products were dispensed in Oregon. The recall covers specific lots distributed between September 1, 2018, and February 20, 2019. The lot numbers are 23012019@48, 24012019@2, 24012019@36, 28012019@35, 29012019@13, 05022019@5, 11022019@13, 12022019@20, 19022019@1, 19022019@6, 19022019@57, and 19022019@61.
Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
- Category
- Drug — Ophthalmic
- Affected units
- 12
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 (13)
- Lots: 23012019@48
- 24012019@2
- 24012019@36
- 28012019@35
- 29012019@13
- 05022019@5
- 11022019@13
- 12022019@20
- 19022019@1
- 19022019@6
- 19022019@57
- 19022019@61
- All lots within expiry 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.
See all 25 products in this recall →Related recalls
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