PEPCID COMPLETE - 25CT
GOLD STAR DISTRIBUTION
Class I - Dangerous
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
DAYQUIL COLD & FLU, 32CT/2PK
GOLD STAR DISTRIBUTION
Class I - Dangerous
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932
GOLD STAR DISTRIBUTION
Class I - Dangerous
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Benadryl, 25'S 2PK Box, UPC 815556020316
GOLD STAR DISTRIBUTION
Class I - Dangerous
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887
Medinatura New Mexico
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class I - Dangerous
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class I - Dangerous
Presence of particulate matter - Glass like particles.
ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863
Medinatura New Mexico
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Signature Formulations
Class I - Dangerous
cGMP Deviations
Class I - Dangerous
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA
Signature Formulations
Class I - Dangerous
cGMP Deviations
Class I - Dangerous
Out of specification for dissolution.
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30
Alembic Pharmaceuticals Limited
Class I - Dangerous
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class I - Dangerous
Presence of particulate matter - Glass like particles.
Class I - Dangerous
Presence of particulate matter - Glass like particles.
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10
Zydus Pharmaceuticals (USA)
Class I - Dangerous
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class I - Dangerous
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class I - Dangerous
Presence of Particulate Matter: Hair was found in a prefilled syringe