Key Takeaway

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 by Pharm D Solutions, LLC was recalled on October 12, 2016. The hazard: Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct

FDA Drug Class III Terminated

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

Recalled: October 12, 2016 ~112 bottles units affected D-0427-2017

Description

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

Hazard / Reason

Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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

Drugs

Company Information

Pharm D Solutions, LLC

Houston, TX, United States

View all 100 recalls by Pharm D Solutions, LLC →

Distribution

AZ and WA

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Frequently Asked Questions

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Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.