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Class III: unlikely to cause harmTerminated

Pharm D Solutions HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial Recall

HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D…

Pharm D Solutions, LLC · Houston, TX

Risk level
Class III
Reported by FDA
Jan 18, 2017
Recall ID
D-0427-2017
Check your lot numberHow we source this data

Summary

Pharm D Solutions recalled HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial starting Oct 12, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0427-2017 on Jan 18, 2017. Reason: Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lots: 07272016:03 Expiration Date: 01/23/2017 and 09142016:88 Expiration Date: 03/07/2017

Where it was sold

AZ and WA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0427-2017
Classification
Class III
Status
Terminated
Recall initiated
Oct 12, 2016
FDA report date
Jan 18, 2017
Quantity
112 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Pharm D Solutions, LLC

Original FDA data

Every field from FDA enforcement report D-0427-2017, exactly as published.

Show all FDA fields
City
Houston
State
TX
Status
Terminated
Country
United States
Event ID
75552
Address
1304 S Loop W
Code information
Lots: 07272016:03 Expiration Date: 01/23/2017 and 09142016:88 Expiration Date: 03/07/2017
Postal code
77054-4010
Report date
Jan 18, 2017
Product type
Drugs
Recall number
D-0427-2017
Classification
Class III
Recalling firm
Pharm D Solutions, LLC
Product quantity
112 bottles
Termination date
May 11, 2017
Reason for recall
Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
AZ and WA
Recall initiation date
Oct 12, 2016
Initial firm notification
E-Mail
Center classification date
Jan 9, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0427-2017, published Jan 18, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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