Recalls / Class II
Class IID-0108-2016
Product
METHYLCOBALAMIN PRESERVATIVE FREE PREFILLED, Injectable Solution, 15 MG/ML, syringe size: 12 mL, 20 mL, 30 mL, 40 mL, 60 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
- 01022015@27, 01212015@13, 02042015@2, 02182015@3, 03042015@3, 03092015@12, 03182015@19, 03252015@7, 04152015@3, 04292015@4, 05112015@2, 05132015@10, 05262015@1, 06032015@6, 06082015@6, 06152015@5, 06242015@3, 06292015@9, 07092014@1, 07292014@35, 08062014@3, 08272014@1, 09292014@12, 10202014@11, 11052014@5, 11262014@7, 12082014@11, 12292014@5, t04032015@17.
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 (12mL) syringe, 204 (20mL) syringe, 3 (30mL) syringes, 3 (40mL) syringes, 1 (60mL) 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-0108-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.