Zydus Pharmaceuticals (USA) Inc recalls Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC…
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Read the official notice →- Date
- 2023-03-22
- Country
- United States
- Brand
- Zydus Pharmaceuticals
- Product
- Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02,…
- Classification
- Class III
- Units
- AZ, OH, MS.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Zydus Pharmaceuticals recalls
- 2024-07-17
US
US
- 2024-06-12
US
Zydus Pharmaceuticals (USA) Inc recalls Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad,…
Failed Impurities/Degradation Specifications.
- 2023-11-15
US
Zydus Pharmaceuticals (USA) Inc recalls Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd,…
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
- 2023-10-11
US
- 2022-08-24
US
Zydus Pharmaceuticals (USA) Inc recalls Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured…
Failed Impurities/Degradation Specifications
Other drugs & medical recalls in the United States
- 2023-03-22
US
OMM Imports, Inc. dba Zero Gravity recalls Recreo Hair Growth Laser Comb
The firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. In addition, the firm failed to provide safety information, reproductions and locations of the…
FDA · DeviceOMM Imports, Inc. dba Zero GravityWorldwide and Nationwide including DC and Puerto RicoOfficial notice →US
Avanos Medical, Inc. recalls BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
FDA · DeviceAvanos Medical, Inc.US Nationwide distribution in the state of Oklahoma.Official notice →US
Teva Pharmaceuticals USA Inc recalls Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL…
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
US
AVEVA Drug Delivery Systems, Inc. recalls Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only,…
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
US
Padagis US LLC recalls Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by…
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
US
Breckenridge Pharmaceutical, Inc recalls Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC…
CGMP Deviations: Potential risk of Cross Contamination