Pharm D Solutions Recalls HCG-Vitamin B12 Injection Due to Labeling Error
Pharm D Solutions is recalling 112 vials of HCG-Vitamin B12 injection because the product description incorrectly states the HCG strength as 7500 units instead of 5000 units.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the use of or exposure to the product is not likely to cause adverse health consequences. The hazard is a minor labeling error regarding the declared strength.
Plain-English summary
Pharm D Solutions, LLC is recalling 112 bottles of HCG-Vitamin B12 5000 IU-8 mg in 10 mL vials. The product is a prescription-only medication intended for subcutaneous and intramuscular injection. The recall is due to a labeling error where the product description incorrectly states the HCG strength as 7500 units instead of the correct 5000 units. The primary panel of the label is correct.
The affected lots are 07272016:03 with an expiration date of 01/23/2017, and 09142016:88 with an expiration date of 03/07/2017. The product was distributed in Arizona and Washington.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-20
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 112
Distribution
Part of a larger recall action
This product is one of 2 recalled by Pharm D Solutions, LLC 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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