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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
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