FDA-Drug2015-11-25Class II
Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Hazard
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Sold states
Nationwide
Affected count
8 prefilled syringes
Manufactured in
4625 N University St, N/A, Peoria, IL, United States
Products
Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-317-2016Don't want to check this manually?
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