Drug Recall Enforcement Reports

What are the Drug Enforcement Reports?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.

The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.

Recall Number Recall Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
D-0620-202210-26-2021Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10
Package NDCs: 30142-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 3,744 bottlesClass IITerminated
D-0613-202210-26-2021Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC, 410 TERRY AVENUE N. SEATTLE, WA 9810. NDC 72288-388-10
Package NDCs: 72288-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 1,296 bottlesClass IITerminated
D-0619-202210-26-2021Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-388-10
Package NDCs: 41250-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 10,800 bottlesClass IITerminated
D-0624-202210-26-2021Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10
Package NDCs: 30142-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 36,864 bottlesClass IITerminated
D-0601-202210-26-2021Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 11673-105-26
Package NDCs: 11673-105-26; 11673-105-28
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 4,992 bottlesClass IITerminated
D-0606-202210-26-2021Severe Congestion No Drip Nasal Spray Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-511-10
Package NDCs: 55910-511-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 21,4824 bottlesClass IITerminated
D-0615-202210-26-2021No Drip Nasal Mist, Oxymetazoline HCl 0.05% Nasal decongestant, 1 FL Oz (30 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-388-10
Package NDCs: 59779-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 64,512 bottlesClass IITerminated
D-0585-202210-26-2021Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC: 59779-946-16CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 37,152 bottlesClass IITerminated
D-0582-202210-26-2021Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 45802-203-26CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 4,176 bottlesClass IITerminated
D-0607-202210-26-2021Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785. NDC 41520-108-10
Package NDCs: 41520-108-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 3,192 bottlesClass IITerminated
D-0605-202210-26-2021Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785. NDC 41520-108-10
Package NDCs: 41520-108-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 7,200 bottlesClass IITerminated
D-0587-202210-26-2021Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed By Perrigo, Allegan, MI 49010. NDC: 0113-8959-26
Package NDCs: 0113-8959-26; 0113-8959-34
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 2,832 bottlesClass IITerminated
D-0591-202210-26-2021Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corp., Minneapolis, MN 55403 NDC: 11673-130-26
Package NDCs: 11673-130-26; 11673-130-28; 11673-130-34
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 26,832 bottlesClass IITerminated
D-0610-202210-26-2021Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-343-10
Package NDCs: 41163-343-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 2,664 bottlesClass IITerminated
D-0604-202210-26-2021Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Packaged by Perrigo Company for: Big Lots Stores, Inc., P.O. Box 28523, Columbus, OH 43228-0523. NDC: 50594-719-10CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 3,168 bottlesClass IITerminated
D-0581-202210-26-2021Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1321-97
Package NDCs: 0536-1321-97
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 4,992 bottlesClass IITerminated
D-0597-202210-26-2021Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentoneville, AR 72716. NDC: 49035-766-16
Package NDCs: 49035-766-16
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 55,656 bottlesClass IITerminated
D-0602-202210-26-2021Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 0113-0020-26
Package NDCs: 0113-0020-26; 0113-0020-28; 0113-0020-34
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 3,024 bottlesClass IITerminated
D-0592-202210-26-2021Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walmart, Inc., Bentonville, AR 72716. NDC: 49035-042-26
Package NDCs: 49035-042-26
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 111,888 bottlesClass IITerminated
D-0622-202210-26-2021No Drip Nasal Decongestant, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009. NDC 21130-801-10
Package NDCs: 21130-801-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 11,088 bottlesClass IITerminated
D-0614-202210-26-2021Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC, 410 TERRY AVENUE N. SEATTLE, WA 9810. NDC 72288-388-10
Package NDCs: 72288-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 26,448 bottlesClass IITerminated
D-0594-202210-26-2021Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-759-26CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 14,688 bottlesClass IITerminated
D-0628-202210-26-2021Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10
Package NDCs: 41250-989-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 2,302 bottlesClass IITerminated
D-0590-202210-26-2021Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC: 55910-251-26
Package NDCs: 55910-251-26; 55910-251-28; 55910-251-34
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 16,992 bottlesClass IITerminated
D-0625-202210-26-2021No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007. NDC 36800-388-10
Package NDCs: 36800-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 13,824 bottlesClass IITerminated
D-0612-202210-26-2021Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC., ELK GROVE VILLAGE, IL 60007. NDC 36800-907-10
Package NDCs: 36800-907-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 19,584 bottlesClass IITerminated
D-0588-202210-26-2021Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-818-26
Package NDCs: 30142-818-26
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 20,448 bottlesClass IITerminated
D-0595-202210-26-2021Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16
Package NDCs: 30142-766-16
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 1,296 bottlesClass IITerminated
D-0784-202210-26-2021artnaturals Hand SanitizerCGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lotVIRGIN SCENT INC / 46,368 BottlesClass IITerminated
D-0783-202210-26-2021artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lotVIRGIN SCENT INC / 570,268 BottlesClass IITerminated
D-0596-202210-26-2021Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16
Package NDCs: 30142-766-16
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 5,184 bottlesClass IITerminated
D-0617-202210-26-2021Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10
Package NDCs: 30142-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 7,632 bottlesClass IITerminated
D-0609-202210-26-2021Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009. NDC 21130-813-10
Package NDCs: 21130-813-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 14,784 bottlesClass IITerminated
D-0616-202210-26-2021Maxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-623-10
Package NDCs: 55910-623-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 123,408 bottlesClass IITerminated
D-0621-202210-26-2021Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6319-1
Package NDCs: 11822-6319-1
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 15,264 bottlesClass IITerminated
D-0579-202210-26-2021Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 50941-009-43CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 14,868 bottlesClass IITerminated
D-0600-202210-26-2021Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo pack. DS SR APAP 160MG CHLD BBGM/DF CHRY/GRP. UPC: 3 70030 11637 9CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.Perrigo Company PLC / 561 bottlesClass IITerminated
D-0230-202210-25-2021Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01
Package NDCs: 16714-074-01; 16714-074-02; 16714-075-01; 16714-076-01; 16714-077-01
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.SUN PHARMACEUTICAL INDUSTRIES INC / 73,957 30-count bottlesClass IITerminated
D-0231-202210-25-2021Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01
Package NDCs: 16714-074-01; 16714-074-02; 16714-075-01; 16714-076-01; 16714-077-01
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.SUN PHARMACEUTICAL INDUSTRIES INC / 36,786 30-count bottlesClass IITerminated
D-0255-202210-25-2021Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05.
Package NDCs: 29300-115-16; 29300-115-01; 29300-115-05; 29300-115-10; 29300-116-16; 29300-116-01; 29300-116-05; 29300-116-10; 29300-117-16; 29300-117-01; 29300-117-05; 29300-117-10; 29300-118-16; 29300-118-01; 29300-118-05; 29300-118-10
DiscolorationUNICHEM PHARMACEUTICALS USA INC / 1284 bottlesClass IIITerminated
D-0361-202210-22-2021Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.
Package NDCs: 47335-686-83; 47335-686-88; 47335-686-08; 47335-686-18; 47335-687-83; 47335-687-88; 47335-687-08; 47335-687-18; 47335-688-83; 47335-688-88; 47335-688-08; 47335-688-18; 47335-689-83; 47335-689-88; 47335-689-08; 47335-689-18; 47335-690-83; 47335-690-88; 47335-690-08; 47335-690-18; 47335-691-83; 47335-691-88; 47335-691-08; 47335-691-18; 47335-692-83; 47335-692-88; 47335-692-08; 47335-692-18; 47335-693-83; 47335-693-88; 47335-693-08; 47335-693-18
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.SUN PHARMACEUTICAL INDUSTRIES INC / 696 BottlesClass IITerminated
D-0091-202210-20-2021Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.Lupin Pharmaceuticals Inc. / 16,272 bottlesClass IIITerminated
D-0258-202210-19-2021Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05Defective ContainerTeligent Pharma, Inc. / 2664 bottlesClass IITerminated
D-0259-202210-19-2021Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05.Defective ContainerTeligent Pharma, Inc. / 5400 unitsClass IITerminated
D-0093-202210-19-2021Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01Presence of Particulate Matter: Identified as Glass ParticlesMERCK SHARP & DOHME CORP / 76,163 vialsClass ITerminated
D-0078-202210-18-2021Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA
Package NDCs: 33342-087-07; 33342-087-46; 33342-087-12; 33342-087-52; 33342-087-50; 33342-087-72; 33342-087-02; 33342-087-45; 33342-087-41; 33342-088-07; 33342-088-46; 33342-088-12; 33342-088-52; 33342-088-50; 33342-088-72; 33342-088-02; 33342-088-45; 33342-088-41
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.MACLEODS PHARMA USA, INC / 135,082 Blister Packs/2,431,476 tabletsClass IIITerminated
D-0080-202210-18-2021Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-094-41
Package NDCs: 33342-093-48; 33342-093-07; 33342-093-46; 33342-093-12; 33342-093-52; 33342-093-73; 33342-093-72; 33342-093-41; 33342-093-45; 33342-093-04; 33342-093-23; 33342-094-47; 33342-094-07; 33342-094-46; 33342-094-12; 33342-094-52; 33342-094-73; 33342-094-72; 33342-094-41; 33342-094-45; 33342-094-04; 33342-094-23
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.MACLEODS PHARMA USA, INC / 643,800 Blister Packs /888,336 TabletsClass IIITerminated
D-0079-202210-18-2021Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41
Package NDCs: 33342-093-48; 33342-093-07; 33342-093-46; 33342-093-12; 33342-093-52; 33342-093-73; 33342-093-72; 33342-093-41; 33342-093-45; 33342-093-04; 33342-093-23; 33342-094-47; 33342-094-07; 33342-094-46; 33342-094-12; 33342-094-52; 33342-094-73; 33342-094-72; 33342-094-41; 33342-094-45; 33342-094-04; 33342-094-23
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.MACLEODS PHARMA USA, INC / 13,260 Blister Packs/238,680 tabletsClass IIITerminated
D-0228-202210-14-2021Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05
Package NDCs: 51407-190-30; 51407-190-90; 51407-190-10; 51407-191-30; 51407-191-90; 51407-191-10; 51407-192-30; 51407-192-90; 51407-192-05; 51407-192-10; 51407-193-30; 51407-193-90; 51407-193-05
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivityGolden State Medical Supply Inc. / 49Class IITerminated
D-0227-202210-14-2021Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05
Package NDCs: 51407-190-30; 51407-190-90; 51407-190-10; 51407-191-30; 51407-191-90; 51407-191-10; 51407-192-30; 51407-192-90; 51407-192-05; 51407-192-10; 51407-193-30; 51407-193-90; 51407-193-05
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottleGolden State Medical Supply Inc. / a) 101 b) 145 bottlesClass IITerminated
D-0076-202210-13-2021Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 42,394,018 tabletsClass IIITerminated
D-0075-202210-13-2021Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 991,310 tabletsClass IIITerminated
D-0071-202210-13-2021Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 1,367,525 tabletsClass IIITerminated
D-0072-202210-13-2021ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label)Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 1,968,150 tabletsClass IIITerminated
D-0077-202210-13-2021Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 519,600 tabletsClass IIITerminated
D-0074-202210-13-2021North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 250,000 tabletsClass IIITerminated
D-0073-202210-13-2021AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 1,480,981 tabletsClass IIITerminated
D-0070-202210-13-2021PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.Ultra Seal Corporation / 2,484,274 tabletsClass IIITerminated
D-0183-202210-12-2021TESTOSTERONE CYPIONATE 30MG/ML #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0172-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.5MG/ML INJ #2 IN SESAME OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 9 vialsClass IITerminated
D-0151-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 23 vialsClass IITerminated
D-0137-202210-12-2021QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 20/ATROPINE 0.1 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0141-202210-12-2021QUAD-MIX PAPAV 30/PHENTOL 3/PGE-1 100/ATROPINE 0.2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0182-202210-12-2021TESTOSTERONE CYPIONATE 25MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 16 vialsClass IITerminated
D-0164-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 2MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0167-202210-12-2021TEST CYPIONATE 200MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0212-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 7 vialsClass IITerminated
D-0163-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 2MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IITerminated
D-0185-202210-12-2021TRI-MIX PAPAV 23.3MG/PHENTOL 1MG/PGE-1 12MCG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0165-202210-12-2021TEST CYPIONATE 200MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 21 vialsClass IITerminated
D-0195-202210-12-2021TRI-MIX PAPAVERINE 25/PHENTOLAMINE 3/PGE-1 80 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0223-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 7.5/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0192-202210-12-2021TRI-MIX PAPAVERINE 18/PHENTOL 0.6/PGE-1 6/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0216-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 100 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0136-202210-12-2021QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 10/ATROPINE 0.15 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0209-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IITerminated
D-0108-202210-12-2021BLUE TREE LIPO EXTREME (/W METHYLCOBALAMIN) INJECTION INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 8 vialsClass IITerminated
D-0119-202210-12-2021IC B COMPLEX INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0140-202210-12-2021QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 30/ATROPINE 0.2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vialsClass IITerminated
D-0180-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ML INJ #2 IN SESAME OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 43 vialsClass IITerminated
D-0168-202210-12-2021TESTOSTERONE BI-BLEND 100/100MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0221-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 5 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0176-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1.75MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0177-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1MG/ML #2 IN SESAME OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 6 vialsClass IITerminated
D-0123-202210-12-2021LEUCINE 10MG/ ISOLEUCINE 15MG/ VALINE 40MG/ML (BCAA) INJ 10MG/15MG/40MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 5 vialsClass IITerminated
D-0219-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0138-202210-12-2021QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 20/ATROPINE 0.2 INJ *C5* INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vialsClass IITerminated
D-0134-202210-12-2021PROGESTERONE 100MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0098-202210-12-2021(WELL'S LIPO-LEAN)INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+ CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE in vials, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0184-202210-12-2021TESTOSTERONE CYPIONATE 50MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 40 vialsClass IITerminated
D-0128-202210-12-2021MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML+LIDO 20/40/50/25/25MG/ML+LIDO INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0105-202210-12-2021ALPROSTADIL 45MCG/ML 45MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0188-202210-12-2021TRI-MIX PAPAVERINE 15/PHENTOLAMINE 1/PGE-1 10 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0189-202210-12-2021TRI-MIX PAPAVERINE 15/PHENTOLAMINE 2/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0190-202210-12-2021TRI-MIX PAPAVERINE 17.65/PHENTOLAMINE 0.59/PGE-1 5.9 INJ **T 101** INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0106-202210-12-2021B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0118-202210-12-2021HYDROXOCOBALAMIN 5,000MCG/ML INJ 5,000MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0152-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.75MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0139-202210-12-2021QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 200/ATROPINE 0.02 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0111-202210-12-2021ESTRADIOL VALERATE 30MG/ML INJ #1 IN ETHYL OLEATE OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated