Class I - Dangerous
Lack of Assurance of Sterility
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Prescription Drugs
💊 Drugs • 12,141 recalls
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04
Teva Pharmaceuticals USA
Class I - Dangerous
Lack of Assurance of Sterility
Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03
Teva Pharmaceuticals USA
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
SigmaPharm Laboratories
Class I - Dangerous
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class I - Dangerous
Failed Impurities/Degradation Specifications
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01
Teva Pharmaceuticals USA
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class I - Dangerous
Subpotent and Presence of Particulates .
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1
Preferred Pharmaceuticals
Class I - Dangerous
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Class I - Dangerous
Presence of foreign substance: identified as activated carbon.
Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.
Class I - Dangerous
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-227-01. Packaged in 150 cc white HDPE bottle
Heritage Pharmaceuticals
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date
Class I - Dangerous
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class I - Dangerous
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class I - Dangerous
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Preferred Pharmaceuticals, Inc., Mfg: Ascend Laboratories, LLC, NDC #: 68788-7529-1,
Preferred Pharmaceuticals
Class I - Dangerous
Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin
Class I - Dangerous
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class I - Dangerous
Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.