0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Fresenius Medical Care Renal Therapies Group
Class I - Dangerous
Lack of Assurance of Sterility
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
Mylan Pharmaceuticals
Class I - Dangerous
CGMP Deviations
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
Mylan Pharmaceuticals
Class I - Dangerous
CGMP Deviations
Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Class I - Dangerous
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
Mylan Pharmaceuticals
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Failed Stability Specifications
MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD Professional LLC, Minneapolis, MN
Milbar Laboratories
Class I - Dangerous
GMP Deviations
Class I - Dangerous
Failed Stability Specifications
Class I - Dangerous
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Class I - Dangerous
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class I - Dangerous
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class I - Dangerous
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00
Aidarex Pharmaceuticals
Class I - Dangerous
Presence of Foreign Tablets/Capsules
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
Mylan Pharmaceuticals
Class I - Dangerous
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.
Milbar Laboratories
Class I - Dangerous
GMP Deviations
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
Mylan Pharmaceuticals
Class I - Dangerous
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Class I - Dangerous
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02
Sun Pharmaceutical Industries
Class I - Dangerous
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.