Class I · High risk Terminated
Tetracycline HCL Capsules
Reason Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Tetracycline 250 mg powder kits packaged with powder and water…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
What was recalled
Tetracycline 250 mg powder kits packaged with powder and water in separate amber glass vials, with filter, in bag, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Recalling firm
- Martin Avenue Pharmacy, Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0141-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Tetracycline recalls
See all
Class I · High risk Terminated
Tetracycline HCL Capsules
Reason Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Class II · Moderate risk Terminated
Diabecline brand Topical Ointment First Aid Antibiotic
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.
Class II · Moderate risk Terminated
TetraStem brand Topical Ointment First Aid Antibiotic
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.
Class II · Moderate risk Terminated
Tetracycline-ABC Brand Topical ointment First Aid Antibiotic
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.
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