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Class II: temporary or reversible health riskTerminated

Clinical Specialties Compounding Pharmacy Test cyp 75 mg-estradiol cyp 5 mg/ml Recall

Test cyp 75 mg-estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Ba…

Clinical Specialties Compounding Pharmacy · Augusta, GA

Risk level
Class II
Reported by FDA
Jul 10, 2013
Recall ID
D-678-2013
Check your lot numberHow we source this data

Summary

Clinical Specialties Compounding Pharmacy recalled Test cyp 75 mg-estradiol cyp 5 mg/ml starting Mar 20, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-678-2013 on Jul 10, 2013. Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Product description

Test cyp 75 mg-estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Lot numbers, UPCs & expiration codes

Lot number CABCAIBB:44, Exp date: 5/7/2013.

Where it was sold

FL, GA and SC.

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-678-2013
Classification
Class II
Status
Terminated
Recall initiated
Mar 20, 2013
FDA report date
Jul 10, 2013
Quantity
11ml
Recall type
Voluntary: Firm initiated
Recalling firm
Clinical Specialties Compounding Pharmacy

Original FDA data

Every field from FDA enforcement report D-678-2013, exactly as published.

Show all FDA fields
City
Augusta
State
GA
Status
Terminated
Country
United States
Event ID
64661
Address
318 Baston Rd
Code information
Lot number CABCAIBB:44, Exp date: 5/7/2013.
Postal code
30907
Report date
Jul 10, 2013
Product type
Drugs
Recall number
D-678-2013
Classification
Class II
Recalling firm
Clinical Specialties Compounding Pharmacy
Product quantity
11ml
Termination date
Feb 22, 2017
Reason for recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Voluntary / mandated
Voluntary: Firm initiated
Product description
Test cyp 75 mg-estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Distribution pattern
FL, GA and SC.
Recall initiation date
Mar 20, 2013
Initial firm notification
Telephone
Center classification date
Jul 3, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-678-2013, published Jul 10, 2013. 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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