Class II · Moderate risk Ongoing
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Reason CGMP Deviations
Is Latanoprost recalled?
11 FDA recalls mention Latanoprost. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Latanoprost.
Class III · Low risk Ongoing
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind…
Reason Failed Release Testing: Out of specification for particulate matter test.
Class II · Moderate risk Terminated
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
Reason Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Class II · Moderate risk Terminated
Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed…
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk Terminated
Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or…
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk Terminated
Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use…
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk Terminated
LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake…
Reason Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Class II · Moderate risk Terminated
Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario…
Reason Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial…
Class II · Moderate risk Terminated
Latanoprost 0.025% eye drop, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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