D-418-2014 Class II Terminated
FDA drug recall D-418-2014 was initiated by Specialty Medicine Compounding Pharmacy on October 19, 2013 and is designated Class II. 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 a… The recall status is terminated (terminated September 22, 2014). Affected quantity: 30 mL.
Recall Details
- Product Type
- Drugs
- Report Date
- January 22, 2014
- Initiation Date
- October 19, 2013
- Termination Date
- September 22, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 mL
Product Description
EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, 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.
Distribution Pattern
Hospitals, clinics, physicians, and patients in the Michigan area only.
Code Information
All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t07312013@36, t09182013@5