Lupin Pharmaceuticals Inc. recalls Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451…
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Read the official notice →- Date
- 2023-08-09
- Country
- United States
- Brand
- Lupin Pharmaceuticals
- Product
- Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451…
- Classification
- Class I
- Units
- USA nationwide.
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Lupin Pharmaceuticals recalls
- 2024-02-07
US
Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland…
Failed Impurities/Degradation Specifications
- 2024-01-17
US
Lupin Pharmaceuticals Inc. recalls Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for:…
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
- 2023-12-20
US
Lupin Pharmaceuticals Inc. recalls Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202…
Failed Dissolution Specifications
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed to 3 wholesale/distributor accounts.Official notice →- 2023-07-19
US
Lupin Pharmaceuticals Inc. recalls Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland…
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed directly to three distributors in TN and NJ. Product…Official notice →- 2023-02-01
US
Lupin Pharmaceuticals Inc. recalls Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202,…
Subpotent Drug: Low assay result observed during long-term stability testing.
- 2023-01-18
US
Lupin Pharmaceuticals Inc. recalls Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202,…
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Other drugs & medical recalls in the United States
- 2023-08-09
US
Microtek Medical Inc. recalls Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case,…
Certain lots of the products have a Naphthalene odor.
FDA · DeviceMicrotek Medical Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice →US
Creganna Medical Devices recalls Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Three lots of product may be labeled with an incorrect expiration day
US
Johnson & Johnson Surgical Vision, Inc. recalls VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the…
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.Worldwide - US Nationwide distribution including in the states of NC, OH, NY,…Official notice →US
Central Admixture Pharmacy Services Inc recalls HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy…
Lack of assurance of sterility: Lack of validation data for sanitization cycles
US
Central Admixture Pharmacy Services, Inc. recalls Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM, total volume = 250mL, IV Bag, Rx Only,…
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
US
The Ritedose Corporation recalls Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not For Inhalation…
CGMP deviation: product released prior to supplier approval.