Class III · Low risk Ongoing
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B…
Reason Tablet/Capsules Imprinted with Wrong ID
Is East recalled?
1,061 FDA recalls mention East. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of East.
Class I · High risk Ongoing
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd…
Reason Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets…
Class II · Moderate risk Ongoing
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed…
Reason Failed Dissolution Specifications.
Class II · Moderate risk Ongoing
Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ…
Reason Presence of foreign substance: Presence of Benzene.
Class II · Moderate risk Ongoing
Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick…
Reason Presence of foreign substance: Presence of Benzene.
Class II · Moderate risk Ongoing
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only…
Reason Failed Dissolution Specifications.
Class II · Moderate risk Ongoing
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by…
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East…
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx…
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road…
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Class II · Moderate risk Ongoing
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC…
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count…
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East…
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class II · Moderate risk Ongoing
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05)…
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05)…
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05)…
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class III · Low risk Terminated
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick…
Reason Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Class I · High risk Ongoing
Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by…
Reason Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Class III · Low risk Ongoing
Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For…
Reason Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Class III · Low risk Ongoing
Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816…
Reason Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered…
Class II · Moderate risk Ongoing
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC…
Reason Discoloration: Dotted and yellow spots on tablets
Class II · Moderate risk Ongoing
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC…
Reason Discoloration: Dotted and yellow spots on tablets
Class II · Moderate risk Terminated
Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle…
Reason CGMP Deviations
Class III · Low risk Terminated
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East…
Reason Failed Impurities/Degradation Specifications
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