Class II · Moderate risk
Broadway Joe's Pain Cream
CGMP Deviations: Potential contamination of raw material
Ketotifen Fumarate 0.025 %
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;
Affected NDCs
17477-0717-10
70518-1142-00
Compare with the code on your package — it is the most precise check available.
Drug: Histamine Category: Eye Drops & Ophthalmic
- Recalling firm
- RemedyRepack Inc.
- NDC code
- 70518-1142-00
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0577-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Histamine recalls
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Class II · Moderate risk
Broadway Joe's Pain Cream
CGMP Deviations: Potential contamination of raw material
Class II · Moderate risk
AbeeMed cream
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Histamine Phosphate active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Histamine Diphosphate active pharmaceutical ingredient packaged…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Other recalls by RemedyRepack Inc.
All 2023 recalls
Class II · Moderate risk
Clindamycin HCl Capsule
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class II · Moderate risk
Clindamycin HCl
CGMP Deviations
Class II · Moderate risk
Carvedilol 25 mg Tablet
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
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