FDA-Drug2016-10-12Class IIPROCESSING DEFECT

The Apothecary Shoppe methylcobalamin injection recalled for sterility assurance failure

OTHEROK

Stop using The Apothecary Shoppe methylcobalamin injection

The Apothecary Shoppe LLC is recalling methylcobalamin 5000 mcg/mL injections because they were sterilized using a filter that was itself recalled. This means the medication may not be sterile and could cause serious infection if injected. No injuries have been reported so far.

  • Stop using any methylcobalamin 5000 mcg/mL vials from The Apothecary Shoppe Compounding Pharmacy in Jenks, Oklahoma with lot codes 071222016 (expires 1/8/2017) or 05112016 (expires 11/7/2016)
  • Contact your doctor or pharmacist immediately for a replacement prescription
  • Do not use or discard the medication yourself; ask your pharmacy how to safely return it
Hazard

Lack of Assurance of Sterility; medication was sterilized with a recalled filter

Sold states
Oklahoma
Affected count
419 mL total
Manufactured in
6136 E 51st St, N/A, Tulsa, OK, United States
Products
Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0002-2017

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