Agency classClass IIOur severity:Severe FDA (Drugs)·D-0990-2016·Announced 2016-06-15

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.

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, 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
Hazard: sterility-failure
gmp-violation
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.

See all 51 products in this recall →

Same manufacturer · Well Care Compounding Pharmacy

See all →

Severe
Phosphatidylcholine/Deoxycholic Acid Injection Recalled for Sterility Concerns
FDA (Drugs) · 2016-06-15
High
FDA Recalls Itraconazole Nasal Spray Due to Sterility Concerns
FDA (Drugs) · 2016-06-15
Moderate
Well Care Compounding Pharmacy Recalls Methylcobalamin Vials for Sterility Concerns
FDA (Drugs) · 2016-06-15
High
Well Care Compounding Pharmacy Recalls Sterility-Compromised Glutathione Vials
FDA (Drugs) · 2016-06-15
Severe
Gentamicin Ophthalmic Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2016-06-15

Same hazard · sterility failure