CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Reported: January 22, 2014 Initiated: October 19, 2013 #D-416-2014
Product Description
CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Details
- Recalling Firm
- Specialty Medicine Compounding Pharmacy
- Units Affected
- 5 mL
- Distribution
- Hospitals, clinics, physicians, and patients in the Michigan area only.
- Location
- South Lyon, MI
Frequently Asked Questions
What product was recalled? ▼
CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178. Recalled by Specialty Medicine Compounding Pharmacy. Units affected: 5 mL.
Why was this product recalled? ▼
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 22, 2014. Severity: Moderate. Recall number: D-416-2014.
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