PlainRecalls
LowClass IIITerminated

FDA Drug recall · Reported January 18, 2017

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

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

Recall #
D-0427-2017
Affected scope
112 bottles
Initiated
October 12, 2016
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
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Pharm D Solutions, LLC recalled HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D So… - a low-severity action.

HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D So… was recalled by Pharm D Solutions, LLC in January 18, 2017. Reason: Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 u…. Check the official notice for the remedy. Verify recall #D-0427-2017 with the FDA Drug before acting.

The recall

Pharm D Solutions, LLC issued this low-severity FDA Drug recall-Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 u….

Low
severity level
Class III
classification
January 18, 2017
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0427-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-0427-2017) was formally reported on January 18, 2017, with the manufacturer initiating the action on October 12, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Pharm D Solutions, LLC is listed as the recalling firm, operating out of Houston, TX. Federal records list the affected scope as 112 bottles.

The documented reason for this recall is: Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct Distribution data in the federal record shows the product reached: AZ and WA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,287 drugs & medications recalls on record

-50005001,0001,5002,000 2006201220152018202120242026 263
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Low

Affected scope

112 bottles

Related Recalls

6

5 from same agency

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

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Low (Class III)
Status Terminated
Recall number D-0427-2017
Date reported January 18, 2017
Date initiated October 12, 2016
Recalling firm Pharm D Solutions, LLC
Firm location Houston, TX
Affected scope 112 bottles
Distribution AZ and WA

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0427-2017) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

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.
Where was the recalled product distributed?
Distribution: AZ and WA.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0427-2017) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported January 18, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.