Methylcobalamin Injection Recalled Due to Sterility Assurance Concerns
Well Care Compounding Pharmacy is recalling Methylcobalamin 1 mg/mL vials because FDA inspections found GMP violations that may impact product 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 in an injectable drug, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling Methylcobalamin 1 mg/mL, packaged in 1 mL and 5 mL vials. The recall involves 869 units distributed in Nevada. The product is prescription-only.
The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency classification for this recall is Class II.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for instructions on return or replacement.
The recalled product
- Product
- METHYLCOBALAMIN 1 MG/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
- 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 (11)
- Lot #: 01062016: 32@16
- Exp.04/06/2016
- Lot #: 01252016: 96@51
- Exp. 07/23/2016
- Lot #: 03302016: 68@42
- Exp. 09/25/2016
- Lot #: 04042016:11@27
- Exp.10/02/2016
- Lot #: 04122016: 90@15
- Exp. 10/09/2016 04202016:57@13
- Exp.10/22/2016.
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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