Class II · Moderate risk
Children's Loratadine Syrup
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
FDA Drug Recalls
36 recalls · Class II, newest first
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Class II · Moderate risk
Hydroxocobalamin Injection Solution 1 mg/mL Inj.
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
Class II · Moderate risk
HydrALAZINE Hydrochloride Tablets
Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.
Class II · Moderate risk
CREON (pancrelipase)
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
Class II · Moderate risk
TOPIRAMATE Tablets 200 mg
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Class II · Moderate risk
Bupivacaine HCl Inj.
Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.
Class II · Moderate risk
ProSol - sulfite-free
Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).
Class II · Moderate risk
Alprazolam Tablets
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Class II · Moderate risk
Alprazolam Tablets
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
Class II · Moderate risk
Metoprolol Succinate Extended-release Tablets
Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol
Class II · Moderate risk
Brevibloc Premixed Injection
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Class II · Moderate risk
Atorvastatin Calcium 40 MG Tablet
Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium
Class II · Moderate risk
Cefpodoxime Proxetil Tablets
Presence of Foreign Substance: Presence of stainless steel particles.
Class II · Moderate risk
Ciprofloxacin 500 mg tablets
Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
Class II · Moderate risk
Mesalamine
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Class II · Moderate risk
Labetalol Hydrochloride Injection
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Class II · Moderate risk
PROMETHAZINE HYDROCHLORIDE Tablets
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Class II · Moderate risk
Famotidine Injection 20 mg
Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
Class II · Moderate risk
0.9% Sodium Chloride Irrigation
Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Class II · Moderate risk
Pristiq (desvenlafaxine)
Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Class II · Moderate risk
LOSARTAN POTASSIUM Tablets
Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning