Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK

FDA recall notice · announced October 12, 2016 · The Apothecary Shoppe

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK

Reason for recall

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

Notes

Distribution: Oklahoma
Lot/code information: 071222016@24 BUD 01/08/2017, 05112016@8 BUD 11/07/2016
Quantity: 419 mL total
Status: Terminated
Products in this recall event:
- Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK (D-0004-2017)
- Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK (D-0003-2017)
- Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK (D-0002-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.