Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by…
Reason Lack of Assurance of Sterility
Is Tetrahydrozoline recalled?
17 FDA recalls mention Tetrahydrozoline. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tetrahydrozoline.
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL)…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY…
Reason Lack of Assurance of Sterility
Class I · High risk Ongoing
Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ…
Reason Non-Sterility
Class I · High risk Ongoing
Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL)…
Reason Non-Sterility
Class I · High risk Ongoing
CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL)…
Reason Non-Sterility
Class I · High risk Ongoing
LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15…
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class II · Moderate risk Ongoing
Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye…
Reason CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class III · Low risk Terminated
Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15…
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk Terminated
Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the…
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk Terminated
Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a)…
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk Terminated
Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Best Choice, DISTRIBUTED BY…
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class II · Moderate risk Terminated
Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.
Reason CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class II · Moderate risk Terminated
Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5
Reason CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class II · Moderate risk Terminated
Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic…
Reason Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list…
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