Class I - Dangerous
GMP Deviations; product may not meet cGMP requirements
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Class I - Dangerous
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
Class I - Dangerous
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class I - Dangerous
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Class I - Dangerous
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class I - Dangerous
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class I - Dangerous
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
Class I - Dangerous
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
Class I - Dangerous
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Class I - Dangerous
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class I - Dangerous
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.
Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Class I - Dangerous
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class I - Dangerous
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Lorazepam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Class I - Dangerous
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Class I - Dangerous
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Vancomycin HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Class I - Dangerous
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Nicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Class I - Dangerous
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Class I - Dangerous
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3
Taro Pharmaceuticals U.S.A.
Class I - Dangerous
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Key Pharmacy and Compounding Center
Class I - Dangerous
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.