FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 0597-0075-41
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Manufacturer: Ricola Ltd., 4242 Laufen, Switzerland; Distributed by: Ricola USA Inc., 6 Campus Drive, 2nd Floor South, Parsippany, NJ 07054. NDC: 54305-507-10
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447.
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., Kurkumbh, India; Manufactured for: Cipla USA, Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156. NDC: 69097-159-15
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. NDC: 23155-002-01
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004. NDC: 69315-127-10
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 Unite States; Manufactured by: Lupin Limited, Nagpur - 441 108, INDIA. NDC 68180-652-08
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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