FDA recall D-1396-2014

John W Hollis Inc · Class II · drug

Product

METHYLCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Methylcobalamin 1000 mcg, Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

Reason for recall

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2014-05-12
Report date
2014-06-25
Termination date
2014-07-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Nashville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1396-2014