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Class II: temporary or reversible health riskTerminated

Phillips Tetracycline-ABC Brand Topical ointment Recall

Tetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3%), 3 mL i…

Phillips Co. · Millerton, OK

Risk level
Class II
Reported by FDA
Jul 12, 2017
Recall ID
D-0947-2017
Check your lot numberHow we source this data

Summary

Phillips recalled Tetracycline-ABC Brand Topical ointment starting Jun 8, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0947-2017 on Jul 12, 2017. Reason: GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm. Status: Terminated.

Why it was recalled

GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.

Product description

Tetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 4307410201

Lot numbers, UPCs & expiration codes

All lots remaining within expiry.

Where it was sold

Nationwide and United Kingdom

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-0947-2017
Classification
Class II
Status
Terminated
Recall initiated
Jun 8, 2017
FDA report date
Jul 12, 2017
Quantity
100-200 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Phillips Co.

Original FDA data

Every field from FDA enforcement report D-0947-2017, exactly as published.

Show all FDA fields
City
Millerton
State
OK
Status
Terminated
Country
United States
Event ID
77526
Address
311 Chikasaw Street
Code information
All lots remaining within expiry.
Postal code
74750
Report date
Jul 12, 2017
Product type
Drugs
Recall number
D-0947-2017
Classification
Class II
Recalling firm
Phillips Co.
Product quantity
100-200 bottles
Termination date
Jul 20, 2020
Reason for recall
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Tetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 4307410201
Distribution pattern
Nationwide and United Kingdom
Recall initiation date
Jun 8, 2017
Initial firm notification
Press Release
Center classification date
Jul 6, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0947-2017, published Jul 12, 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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