Well Care Compounding Pharmacy Recalls Injectable Vitamin Mixture for Sterility Concerns
Well Care Compounding Pharmacy is recalling 869 vials of a compounded injectable vitamin mixture due to FDA inspection findings that raised concerns about product 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 in an injectable product, which poses a significant risk of serious injury or death if contaminated, fitting the 'Severe' criteria for significant injury risk.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of a compounded injectable product containing methylcobalamin, hydroxocobalamin, folic acid, pyridoxal-5-phosphate, and lidocaine. The product is packaged in 5mL vials and is available by prescription only.
The recall was initiated after an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impacted the quality and sterility of the product. The source text does not report any specific illnesses or injuries associated with the use of these vials.
The affected lots are distributed in Nevada. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Compounded 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 (8)
- Lot #: 01182016:46@7
- Exp.04/17/2016
- Lot #: 02192016 60@29
- Exp. 05/19/2016
- Lot #: 04082016:83@53
- Exp. 07/11/2016
- Lot #: 04202016:61@66
- Exp.07/19/2016.
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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