Class II · Moderate risk Terminated
Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57
Reason Lack of Processing Controls.
Is Polyethylene recalled?
37 FDA recalls mention Polyethylene. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Polyethylene.
Class II · Moderate risk Terminated
Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle…
Reason Presence of Particulate Matter
Class II · Moderate risk Terminated
Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC…
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
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
Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-10). The products are packaged in Low Density…
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients…
Class III · Low risk Terminated
Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50). The products are packaged in Low Density…
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients…
Class III · Low risk Terminated
Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). The products are packaged in Low Density…
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients…
Class III · Low risk Terminated
Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50). The products are packaged in Low Density…
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients…
Class III · Low risk Terminated
Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The products are packaged in Low Density Polyethylene…
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients…
Class III · Low risk Terminated
Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are packaged in Low Density Polyethylene (LDPE)…
Reason Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients…
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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