Noven Pharmaceuticals Inc recalls Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside…
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Read the official notice →- Date
- 2024-11-27
- Country
- United States
- Brand
- Noven Pharmaceuticals
- Product
- Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a…
- Classification
- Class II
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Noven Pharmaceuticals recalls
- 2023-03-29
US
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by…
Defective Delivery System: Out of specification for shear.
- 2022-12-07
US
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for…
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
- 2022-07-06
US
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for…
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
- 2022-06-01
US
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for…
Defective Delivery System: customer complaints exceeded respective action limits.
Other drugs & medical recalls in the United States
- 2024-11-27
US
Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using…
FDA · DeviceBaxter Healthcare CorporationWorldwide Distribution (US Nationwide distribution)Official notice →US
Evaric Pharmaceuticals Inc. recalls Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for:…
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
US
Safecor Health, LLC recalls Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
US
Lupin Pharmaceuticals Inc. recalls Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02)…
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed to 30 wholesalers/distributors who may have further…Official notice →US
US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive,…
Failed Impurity/Degradation Specifications
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide within the United StatesOfficial notice →