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Class II: temporary or reversible health riskOngoing

Tri-Coast Pharmacy Hcg 5 Recall

HCG 5,000 IU Vial

Tri-Coast Pharmacy · Juno Beach, FL

Risk level
Class II
Reported by FDA
Jan 11, 2017
Recall ID
D-0261-2017
Check your lot numberHow we source this data

Summary

Tri-Coast Pharmacy recalled Hcg 5 starting Nov 17, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0261-2017 on Jan 11, 2017. Reason: Lack of Assurance of Sterility. Status: Ongoing.

Why it was recalled

Lack of Assurance of Sterility

Product description

HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy.

Lot numbers, UPCs & expiration codes

Lot codes: 06222016D, 06062016C, 07192016C07062016A, 08182016B, 08112016A, 08012016A, 09282016A, 09122016D, 10182016C, 11042016B, 11012016F; Exp. 11/16

Where it was sold

Nationwide

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-0261-2017
Classification
Class II
Status
Ongoing
Recall initiated
Nov 17, 2016
FDA report date
Jan 11, 2017
Quantity
4,884 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Tri-Coast Pharmacy

Original FDA data

Every field from FDA enforcement report D-0261-2017, exactly as published.

Show all FDA fields
City
Juno Beach
State
FL
Status
Ongoing
Country
United States
Event ID
75763
Address
14125 US Highway 1
Code information
Lot codes: 06222016D, 06062016C, 07192016C07062016A, 08182016B, 08112016A, 08012016A, 09282016A, 09122016D, 10182016C, 11042016B, 11012016F; Exp. 11/16
Postal code
33408-1425
Report date
Jan 11, 2017
Product type
Drugs
Recall number
D-0261-2017
Classification
Class II
Recalling firm
Tri-Coast Pharmacy
Product quantity
4,884 vials
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy.
Distribution pattern
Nationwide
Recall initiation date
Nov 17, 2016
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Jan 4, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0261-2017, published Jan 11, 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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