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Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

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2,003 recalls · newest first

Food & drug recall · FDAJuly 20, 2018Highest risk

King Bio Inc. — Dr. King's Natural Medicine Kids Sleep Aid Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955042426, NDC 57955-0424-2

Prescription medicine · King Bio Inc. · 2404 bottles affected

Microbial contamination

Food & drug recall · FDAJuly 20, 2018Highest risk

King Bio Inc. — Dr. King's Natural Medicine for kids! Children's Growth & Development Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955514220, NDC 57955-5142-2

Prescription medicine · King Bio Inc. · 124 bottles affected

Microbial contamination

Food & drug recall · FDAJuly 20, 2018Highest risk

King Bio Inc. — Dr. King's Natural Medicine Kids Stress & Anxiety Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955042327, NDC 57955-0423-2

Prescription medicine · King Bio Inc. · 3071 bottles affected

Microbial contamination

Food & drug recall · FDAJuly 20, 2018Highest risk

King Bio Inc. — Dr. King's Natural Medicine for kids! Newborn Tonic Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955511427, NDC 57955-5114-2

Prescription medicine · King Bio Inc. · 84 bottles affected

Microbial contamination

Food & drug recall · FDAJuly 20, 2018Highest risk

King Bio Inc. — Dr. King's Natural Medicine for kids! Children's Fever Reliever Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955515920, NDC 57955-5159-2

Prescription medicine · King Bio Inc. · 873 bottles affected

Microbial contamination

Food & drug recall · FDAJuly 20, 2018Highest risk

King Bio Inc. — Dr. King's Natural Medicine Children's Appetite Enhancer for kids! Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955531821, NDC 57955-5318-2

Prescription medicine · King Bio Inc. · 893 bottles affected

Microbial contamination

Food & drug recall · FDAJuly 20, 2018Highest risk

King Bio Inc. — Dr. King's Natural Medicine for kids! Attention & Learning Enhancement Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955501527, NDC 57955-5015-2

Prescription medicine · King Bio Inc. · 1083 bottles affected

Microbial contamination

Food & drug recall · FDAJuly 20, 2018Highest risk

King Bio Inc. — Dr. King's Baby Colic Relief Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955515821, NDC 57955-0466-2

Prescription medicine · King Bio Inc. · 257 bottles affected

Microbial contamination

Food & drug recall · FDAJune 12, 2018Serious

Avella of Deer Valley, Inc. Store 38 — fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL) 5 mcg in 0.5 mL. Volume: 0.5 mL. Single dose syringe. For Cook Children's Med Ctr. By: Advanced Pharma, 9265 Kir

Prescription medicine · Avella of Deer Valley, Inc. Store 38 · 100 syringes affected

Lack of Assurance of Sterility: Potential leakage of bags.

Food & drug recall · FDASeptember 21, 2017Serious

Medline Industries Inc — Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093

Prescription medicine · Medline Industries Inc · 288 cases affected

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Food & drug recall · FDAApril 21, 2017Highest risk

Hospira Inc. — Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10

Prescription medicine · Hospira Inc. · 71,550 syringes affected

Presence of Particulate Matter: human hair found within an internal sample syringe.

Food & drug recall · FDAApril 18, 2017Labelling issue

Sun Pharmaceutical Industries, Inc. — Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle

Prescription medicine · Sun Pharmaceutical Industries, Inc. · 13,200 bottles affected

Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.

Food & drug recall · FDAFebruary 22, 2017Serious

Advanced Pharma Inc. — Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Prescription medicine · Advanced Pharma Inc.

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Food & drug recall · FDANovember 18, 2016Serious

Raritan Pharmaceuticals, Inc. — CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket RI 02895 NDC 59779-687-02 UPC 77815909639

Prescription medicine · Raritan Pharmaceuticals, Inc. · 20,448 bottles affected

CGMP Deviations

Food & drug recall · FDANovember 18, 2016Serious

Raritan Pharmaceuticals, Inc. — Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd. Montreal, QC H1N 2H2 Canada NDC 60512-913-8 UPC 77815909639

Prescription medicine · Raritan Pharmaceuticals, Inc. · 22,704 bottles affected

CGMP Deviations

Food & drug recall · FDAJuly 15, 2016Labelling issue

Teva North America — Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample

Prescription medicine · Teva North America · 193,320 canisters affected

Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.

Food & drug recall · FDAJune 7, 2016Labelling issue

Lyne Laboratories, Inc. — Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only

Prescription medicine · Lyne Laboratories, Inc. · 12,215 Bottles shipped to Rising Pharmaceuticals affected

Subpotency: product assayed and found OOS for cyproheptadine

Food & drug recall · FDAJanuary 8, 2016Serious

Perrigo Company PLC — Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor

Prescription medicine · Perrigo Company PLC · N/A affected

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

Food & drug recall · FDAJanuary 8, 2016Serious

Perrigo Company PLC — Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus

Prescription medicine · Perrigo Company PLC · N/A affected

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

Food & drug recall · FDAJuly 28, 2015Labelling issue

Ohm Laboratories, Inc. — Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-0161-52, ABC # 042-226, UPC 0 8770140650 8; b) For adults 10-count tablets, ND

Prescription medicine · Ohm Laboratories, Inc. · N/A affected

Superpotent Drug: Out Of Specification (OOS) result for Assay.

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