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Class I: serious health riskOngoing

Complete Pharmacy and Medical Solutions Human Chorionic Gonadotropin Recall

Human Chorionic Gonadotropin, 125 IU HCG, in 0

Complete Pharmacy and Medical Solutions LLC · Miami Lakes, FL

Risk level
Class I
Reported by FDA
Jun 21, 2017
Recall ID
D-0917-2017
Check your lot numberHow we source this data

Summary

Complete Pharmacy and Medical Solutions recalled Human Chorionic Gonadotropin starting Dec 29, 2015. The FDA classified it as Class I (serious health risk) and published enforcement report D-0917-2017 on Jun 21, 2017. Reason: Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture. Status: Ongoing.

Why it was recalled

Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.

Product description

Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014

Lot numbers, UPCs & expiration codes

Lot # 2079ps5, Exp 02/01/2016

Where it was sold

Distributed throughout Florida

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-0917-2017
Classification
Class I
Status
Ongoing
Recall initiated
Dec 29, 2015
FDA report date
Jun 21, 2017
Quantity
1890 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Complete Pharmacy and Medical Solutions LLC

Original FDA data

Every field from FDA enforcement report D-0917-2017, exactly as published.

Show all FDA fields
City
Miami Lakes
State
FL
Status
Ongoing
Country
United States
Event ID
76678
Address
5829 Nw 158th St
Code information
Lot # 2079ps5, Exp 02/01/2016
Postal code
33014-6721
Report date
Jun 21, 2017
Product type
Drugs
Recall number
D-0917-2017
Classification
Class I
Recalling firm
Complete Pharmacy and Medical Solutions LLC
Product quantity
1890 syringes
Reason for recall
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
Distribution pattern
Distributed throughout Florida
Recall initiation date
Dec 29, 2015
Initial firm notification
E-Mail
Center classification date
Jun 13, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0917-2017, published Jun 21, 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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