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.
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 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
Same manufacturer · Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
See all →- SevereFDA Recalls Compounded Sodium Chloride Eye Drops Due to Insanitary Conditions
FDA (Drugs) · 2019-04-17
- SevereFDA Recalls Compounded Papaverine-Phentolamine-PGE1 Injectable Due to Insanitary Conditions
FDA (Drugs) · 2019-04-17
- SevereFDA Recalls Compounded Injectable Drug Due to Insanitary Compounding Conditions
FDA (Drugs) · 2019-04-17
- Severe
- Severe
Same hazard · contamination
See all →- ModerateAVID Medical Recalls GYN Laparoscopy Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAvid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- SevereNatures Pharmacy Recalls Dexamethasone Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2014-03-12
- SevereDexamethasone Solution Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2014-01-22
- SeverePromise Pharmacy Recalls Prednisolone and Moxifloxacin Eye Drops for Sterility Concerns
FDA (Drugs) · 2019-02-20
- SevereFDA Recalls Prednisolone Sodium Phosphate Eye Drops for Sterility Concerns
FDA (Drugs) · 2014-11-12
- SevereNatures Pharmacy Recalls Dexamethosone/Tobramycin Ophthalmic Drops for Sterility Concerns
FDA (Drugs) · 2014-03-12
- SevereUS Compounding Recalls Prednisolone Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2015-11-25