FDA Recalls Compounded HCG and Vitamin Injections for Sterility Concerns
Well Care Compounding Pharmacy is recalling compounded HCG, methylcobalamin, and folic acid injections due to FDA inspection findings regarding sterility assurance.
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, which corresponds to a Severe rating under the rubric, particularly given the risk of sterility failure in an injectable medication.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for compounded HCG/Methylcobalamin/Folic Acid injections manufactured by Well Care Compounding Pharmacy in Las Vegas, Nevada. The product is packaged in 5 mL vials and is available by prescription only. The recall involves a total of 869 units distributed within Nevada.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. Specifically, there is a lack of assurance of sterility for the affected lots.
Consumers who have purchased or received this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The affected lots include those with expiration dates ranging from May 30, 2016, to July 17, 2016.
The recalled product
- Product
- HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL 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 #: 03012016:82@33
- Exp. 05/30/2016
- Lot #: 03012016:65@41
- Exp. 06/16/2016
- Lot #: 04142016:89@48
- Exp. 07/12/2016
- Lot #: 04142016: 28@49
- Exp. 07/17/2016
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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