Class II · Moderate risk
Copaxone (glatiramer acetate injection)
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Particulate & foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables.
867 FDA drug recalls with this cause, newest first.
These recalls involve visible foreign material - glass, metal, fibers, rubber or other debris - most often found in injectable or liquid products, where nothing besides the intended ingredients should be present. It also includes foreign tablets or capsules found in a bottle of a different product. In an injectable a stray particle can go straight into the bloodstream, which is why a noticeable share of these recalls are Class I.
Class III · Low risk
Endocet (oxycodone and acetaminophen)
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
Class II · Moderate risk
Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
Class II · Moderate risk
Epinephrine Injection
Presence of Particulate Matter
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
Class II · Moderate risk
Dr. Reddy's Ciprofloxacin Tablets
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets
Class II · Moderate risk
Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.
Class II · Moderate risk
Metformin Hydrochloride Tablets
Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.
Class II · Moderate risk
Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX
Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
Class II · Moderate risk
Physicians Total Care
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Class II · Moderate risk
Physicians Total Care
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Class I · High risk
Argatroban Injection 50 mg per 50ml
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
Class III · Low risk
Percocet 10/325 mg tablets
Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form.
Class II · Moderate risk
Concentrated Sodium Chloride Injection
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
Class II · Moderate risk
Procrit (epoetin alfa)
Presence of Particulate Matter: glass delamination
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.