Recalls / Class II
Class IID-0092-2016
Product
GLUTATHIONE MDV, Injectable Solution, 200 mg/mL, syringe sizes: 60 mL, 90 mL; 100 mL; and 150 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
- Affected lot / code info
- t12012014@6, t09182014@28, t09162014@31, t09162014@22, t08292014@6, t08122014@26, t07222014@15, t05262015@13, t01192015@11, t05082015@4, t04202015@13
Why it was recalled
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Recalling firm
- Firm
- JD & SN Inc., dba Moses Lake Professional Pharmacy
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1555 Pilgrim St, N/A, Moses Lake, Washington 98837-4623
Distribution
- Quantity
- 1 (60mL) syringe, 3 (90mL) syringe, 5 (100mL) syringe, 1 (150mL) syringe
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-07-24
- FDA classified
- 2015-10-27
- Posted by FDA
- 2015-11-04
- Terminated
- 2016-04-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0092-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.