cGMP Deviations: lack of quality assurance at the API manufacturer.
Prescription Drugs
💊 Drugs • 12,141 recalls
Ondansetron HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Nalbuphine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Rocuronium Bromide all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Labetalol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Heparin sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Ofirmev (Acetaminophen) injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Methohexital Sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Gentamicin Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Children'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.
Sun Pharmaceutical Industries
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52.
Vintage Pharmaceuticals LLC
Superpotent Drug: above specification for the assay.
Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Defective Delivery System: Elevated number of units with out of specification results for leak rate
Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Cefazolin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.