The Recall Desk
SevereFDA (Drugs)·D-1002-2016·Announced 2016-06-15

Well Care Compounding Pharmacy Recalls Methylcobalamin/Folic Acid Vials

Well Care Compounding Pharmacy is recalling Methylcobalamin/Folic Acid vials due to GMP violations that may impact sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility, which poses a significant risk of harm.

Plain-English summary

Well Care Compounding Pharmacy is recalling Methylcobalamin/Folic Acid 10mg/0.8mg/mL vials. The recall involves 869 units distributed in Nevada.

The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency classifies this as a Class II recall.

Patients who have received this medication should contact their healthcare provider for guidance on next steps.

The recalled product

Product
METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Manufacturer
Well Care Compounding Pharmacy
Category
Drug — Injectable Medication
Hazard
Affected units
869

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 (10)

  • Lot #: 01262016:86@2
  • Exp. 07/30/2016
  • 02222016:31@27
  • Exp. 08/20/2016
  • Lot #: 03022016:1@47
  • Exp. 08/29/2016
  • Lot #: 03032016:26@ 1
  • Exp. 08/30/2016
  • Lot #: 04122016: 84@227
  • Exp.10/15/2016.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 51 recalled by Well Care Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 51 products in this recall →

Related recalls

Same manufacturer · Well Care Compounding Pharmacy

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Same hazard · sterility

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