Class II · Moderate risk Terminated
Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA…
Reason Penicillin Cross Contamination
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA…
Reason Penicillin Cross Contamination
Class II · Moderate risk Terminated
Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465…
Reason Penicillin Cross Contamination
Class II · Moderate risk Terminated
Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA…
Reason Penicillin Cross Contamination
Class II · Moderate risk Terminated
Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made…
Reason Penicillin Cross Contamination
Class II · Moderate risk Terminated
Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA…
Reason Penicillin Cross Contamination
Class II · Moderate risk Terminated
Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465…
Reason Penicillin Cross Contamination
Class II · Moderate risk Terminated
All sterile drugs compounded between 2/21/14 and 2/24/14.
Reason Lack of Assurance of Sterility: All compounded products.
Class II · Moderate risk Terminated
Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by…
Reason Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual…
Class II · Moderate risk Terminated
etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL…
Reason Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or…
Class II · Moderate risk Terminated
BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075…
Reason Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q…
Class II · Moderate risk Terminated
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in…
Reason Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to…
Class II · Moderate risk Terminated
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in…
Reason Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to…
Class II · Moderate risk Terminated
Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A…
Reason Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Class II · Moderate risk Terminated
Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c)…
Reason Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09
Reason Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual…
Class II · Moderate risk Terminated
Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue…
Reason Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.
Class II · Moderate risk Terminated
Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL…
Reason Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
Class II · Moderate risk Terminated
Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg , Loratadine, USP, 10 mg…
Reason Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release…
Class II · Moderate risk Terminated
Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC…
Reason Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.
Class II · Moderate risk Terminated
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
Reason Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Class II · Moderate risk Terminated
HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01
Reason Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Class II · Moderate risk Terminated
GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by…
Reason Defective Container: Tamper evident ring failures discovered on some bottles.
Class II · Moderate risk Terminated
Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150…
Reason Failed Tablet Specifications: Broken Tablets Present.
Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient…
Reason Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping