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
Reported: January 18, 2017 Initiated: October 12, 2016 #D-0427-2017
Product 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
Reason for Recall
Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct
Details
- Recalling Firm
- Pharm D Solutions, LLC
- Units Affected
- 112 bottles
- Distribution
- AZ and WA
- Location
- Houston, TX
Frequently Asked Questions
What product was recalled? ▼
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 by Pharm D Solutions, LLC. Units affected: 112 bottles.
Why was this product recalled? ▼
Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 18, 2017. Severity: Low. Recall number: D-0427-2017.
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