The Recall Desk
HighFDA (Drugs)·D-1208-2022·Announced 2022-07-20

Hydroxocobalamin Compounded Injections Recalled for Lack of Sterility Assurance

Tailor Made Compounding is recalling 63 vials of Hydroxocobalamin 25mg/mL injectable solution nationwide due to lack of assurance of sterility. Consumers should not use affected batches.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a compounded injectable pharmaceutical. The hazard—lack of sterility assurance—poses genuine risk of contamination and infection, but no illnesses or injuries have been reported. Per the rubric, this qualifies as High (3): a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Tailor Made Compounding is recalling 63 vials of Hydroxocobalamin 25mg/mL injectable solution distributed nationwide in the United States and Puerto Rico. The recalled product consists of four batches: #12222104A2 (Exp 3/22/2022), #01032224A2 (Exp 4/3/2022), #01282217A2 (Exp 4/28/2022), and #02192211A1 (Exp 5/20/2022).

The recall has been initiated due to lack of assurance of sterility. Sterility is a critical manufacturing requirement for injectable drugs; if not maintained, injectable products may become contaminated, potentially causing infection or other serious adverse health effects in patients who receive them.

Healthcare providers and patients who may have these vials in their possession should not use the product. Users should contact Tailor Made Compounding or the FDA with questions about the recall or if they have additional information about affected vials.

The recalled product

Product
Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding
Manufacturer
TMC Acquisition LLC dba Tailor Made Compounding
Category
Drug — Injectable Compounded
Hazard
  • lack-of-sterility

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Batch#: 12222104A2
  • Exp 3/22/2022
  • 01032224A2
  • Exp 4/3/2022
  • 01282217A2
  • Exp 4/28/2022
  • 02192211A1
  • Exp 5/20/2022.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category