Drug and pharmaceutical recalls
17625 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-05-31FDA-DrugMylan Pharmaceuticals Inc.Class IIITarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured for: Afaxys, Inc., Charleston, SC 29403, USA, Product of India.
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
- 2017-05-31FDA-DrugVintage Pharmaceuticals LLC, DBA Qualitest PharmaceuticalsClass IIIHYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52.
Superpotent Drug: above specification for the assay.
- 2017-05-31FDA-DrugStrides Pharma INCClass IIIBenzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
- 2017-05-31FDA-DrugSun Pharmaceutical Industries, Inc.Class IIIChildren's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
- 2017-05-31FDA-DrugSato Pharmaceutical Inc.Class IIDORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-020-01
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
- 2017-05-31FDA-DrugSato Pharmaceutical Inc.Class IISATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-044-01
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
- 2017-05-31FDA-DrugSato Pharmaceutical Inc.Class IIOptic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-501-01.
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIFentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIFentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IISodium Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IISodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIPotassium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIMagnesium Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IICardioplegic Solution Maintenance all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIDexmedetomidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIDexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIBumetadine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIOndansetron HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIFamotidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIBetamethasone Sodium Phosphate & Betamethasone Acetate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIAtropine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IINeostigmine Methylsulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIGlycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIEsmolol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IILabetalol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIRocuronium Bromide all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IINicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IINitroglycerin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IIAdenosine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- 2017-05-31FDA-DrugAdvanced Pharma Inc.Class IISuccinylcholine Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
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