ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Reported: June 15, 2016 Initiated: May 17, 2016 #D-0980-2016
Product Description
ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Details
- Recalling Firm
- Well Care Compounding Pharmacy
- Units Affected
- 869 Units (All Products)
- Distribution
- NV
- Location
- Las Vegas, NV
Frequently Asked Questions
What product was recalled? ▼
ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121. Recalled by Well Care Compounding Pharmacy. Units affected: 869 Units (All Products).
Why was this product recalled? ▼
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 15, 2016. Severity: Moderate. Recall number: D-0980-2016.
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