Archive
857 recalls were announced in June 2022.
Of the 857 recalls this month scored against our rubric, 3% are Critical, 27% are Severe.
Which agencies issued them
Noven Pharmaceuticals is recalling Daytrana methylphenidate transdermal patches from Lot 90764 (expiration 08/2022) distributed nationwide due to defects in the delivery system. The recall was initiated after customer complaints exceeded FDA action limits.
Olympia Compounding Pharmacy recalls QM-4, a multi-drug compounded injectable, due to lack of assured sterility. 914 vials distributed nationwide in the USA, Puerto Rico, and US Virgin Islands are affected.
Olympia Compounding Pharmacy is recalling 1,306 vials of Pyridoxine HCL 100 mg/mL injection due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy is recalling 1,597 vials of Magnesium Chloride injection due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
Bimix-3 compounded injectable (1,287 vials) recalled nationwide due to lack of sterility assurance. Patients should consult their healthcare provider about whether they received affected product.
RemedyRepack Inc. is recalling Losartan HCTZ 100/25 mg tablets distributed in Florida, South Carolina, and Virginia due to azido impurity levels exceeding acceptable manufacturing limits.
Olympia Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 0.3% Injection due to lack of sterilization assurance. The 943 vials of this injectable product were distributed nationwide and may not meet sterile manufacturing requirements.
Olympia Compounding Pharmacy is recalling pharmaceutical diluent vials due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy is recalling 9,102 vials of Phenylephrine 1 mg/mL due to lack of assurance of sterility. The affected vials were distributed nationwide in the United States, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy is recalling Vitamin D3 injectable vials due to lack of sterility assurance. A total of 3,083 vials were distributed nationwide.
Olympia Compounding Pharmacy recalls 1282 vials of Cyanocobalamin 2 mg/mL due to lack of sterility assurance. The affected vials were distributed nationwide in the United States, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy is recalling 1,291 vials of Zinc Chloride injectable nationwide due to lack of assurance of sterility.
ProgenaCare is recalling progenamatrix Human Keratin Matrix due to inadequate inner pouch seals that may compromise sterility. The recall affects 547 packages distributed in Alabama, Georgia, Florida, Tennessee, and Texas.
ConvaTec is recalling 600 market units of SUR-FIT Natura S4S Durahesive Wafer due to skin barrier delamination. The wafer's layers or tape borders may fail to maintain proper seal, potentially affecting skin protection.
Umano Medical recalls 228 adjustable hospital beds due to potential electrical system failure that could cause uncontrolled movement of the motorized wheel system.
Medtronic is recalling 1,236 units of the Cardioblate Gemini-s surgical ablation system due to an increase in complaints about fractured jaw tips. The device is used in cardiac ablation procedures worldwide.
Devicor Medical Products is recalling 90 HydroMARK Breast Biopsy Markers due to mismatched patient labels that incorrectly identify the product model. The small patient label identifies the device as model 4010-05-08-T3, while the correct model is 4010-05-08-T4.
Stradis Healthcare is recalling 7,340 units of Surgical Suture Kit due to uncertainty about sterilization methods that ensure sterile barrier integrity. Affected lots should not be used.
Umano Medical is recalling 355 adjustable medical beds because an electrical system component failure could cause the motorized wheel system to move uncontrollably, risking patient injury.
Olympus Corporation recalled 1,386 units of Disposable Grasping Forceps FG-51D due to noncompliance with force standards for opening and closing the devices.
Accriva Diagnostics distributed an unclearred variant of the VerifyNow P2Y12 platelet test that displays different results than the FDA-cleared device. A correction formula has been provided to healthcare providers.
A medical lab reagent (ABX Pentra Calcium AS CP) was shipped at room temperature instead of refrigerated, causing probable quality control failure. Affected patients may experience diagnostic delays and require repeat testing.
Olympia Compounding Pharmacy is recalling an injectable medication vial due to lack of sterility assurance. The recall affects 606 vials distributed nationwide, Puerto Rico, and US Virgin Islands.
First & Ten Hot Sauce (11.5 oz bottles) is being recalled due to undeclared milk allergen. The product label declares butter but does not list milk as an allergen.
H-E-B Grocery Company recalls HEB Bakery Two-Bite Brownies due to potential metal fragments in the product. Affected packages were distributed in Texas.
Mrs. Miller's Homemade Jam Spicy Chili Bacon Jam is being recalled for undeclared soy allergen. The product was distributed across 15 U.S. states. Consumers with soy allergies should not consume it.
Olympia Compounding Pharmacy is recalling 1,466 vials of Sodium Bicarbonate 8.4% Multi-Dose Injectable (Lot L41002) due to lack of assurance of sterility. The product was distributed nationwide.
Olympia Compounding Pharmacy is recalling 3,286 vials of Alpha Lipoic Acid 25 mg/mL due to inability to assure sterility. Patients should contact their healthcare provider to verify their medication and discuss alternatives.
Olympia Compounding Pharmacy recalls a multi-drug injectable compound (lot B41C22-22) due to inability to assure sterility. The recall affects 1,159 vials distributed nationwide.
Olympia Compounding Pharmacy recalls Methylcobalamin 5 mg/mL injectable due to lack of assurance of sterility. Approximately 12,800 vials were distributed nationwide.
Olympia Compounding Pharmacy is recalling 205 vials of Formula F9 injectable medication nationwide due to lack of assurance of sterility. The FDA has classified this as a Class II recall.
Olympia Compounding Pharmacy is recalling SB-5, a multi-dose injectable medication, due to lack of assurance of sterility. The product was distributed nationwide; patients should contact their healthcare provider immediately.
Olympia Compounding Pharmacy is recalling AT-6, a compounded injectable medication, due to lack of sterility assurance. The recall affects 528 vials from Lot K24409.
Olympia Compounding Pharmacy recalls Testosterone Cypionate injectable vials distributed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.
Olympia Compounding Pharmacy is recalling 520 vials of Ultratest testosterone injectable due to lack of sterility assurance. The recall affects distribution nationwide in the USA, Puerto Rico, and US Virgin Islands.
RemedyRepack Inc. is recalling Losartan HCTZ 50/12.5 mg tablets due to elevated AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled product was distributed to Florida.
Olympia Compounding Pharmacy is recalling 2,441 vials of Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL injectable due to lack of sterility assurance. The affected vials were distributed nationwide, in Puerto Rico, and the US Virgin Islands.
Olympia Compounding Pharmacy recalled 1,710 vials of RE-2 injectable medication due to lack of assurance of sterility. Affected vials were distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
Olympia Compounding Pharmacy is recalling injectable Lipostat Plus SF vials due to inability to assure sterility. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy is recalling 5,334 vials of MICC injectable due to lack of sterility assurance. Distribution was nationwide in the USA, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy has recalled 8,664 vials of Olympia Vita-Complex B-vitamin injection nationwide due to lack of assurance of sterility. The affected multi-dose vials may pose an infection risk to patients who receive the product.
Olympia Compounding Pharmacy is recalling SB-6, a compounded injectable medication, due to lack of assurance of sterility. The recall affects 874 vials distributed nationwide, in Puerto Rico, and the US Virgin Islands.
Olympia Compounding Pharmacy is recalling QM-3, a multi-dose compounded injectable, due to lack of sterility assurance. The recall includes 414 vials distributed nationwide.
Olympia Compounding Pharmacy is recalling 5,443 vials of Calcium Chloride 10% injectable due to lack of sterility assurance. The medication was distributed nationwide.
Preferred Pharmaceuticals recalls Losartan Potassium & HCTZ Tablets (50mg/12.5mg) in Florida and California due to elevated azido impurity levels above acceptable manufacturing limits.
Olympia Compounding Pharmacy recalls 6,113 vials of Olympia Mineral Blend injectable due to lack of assurance of sterility. The product was distributed nationwide; patients should not use it and should consult their healthcare provider.
Olympia Compounding Pharmacy is recalling NAD+ Nicotinamide Adenine Dinucleotide powder vials nationwide due to lack of assurance of sterility. The recall affects 8,982 vials distributed across the USA, Puerto Rico, and US Virgin Islands.
Direct Rx recalled Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels exceeding acceptable limits. The recall affects 11 bottles distributed in Florida.
Calvin Scott & Company recalled Benzphetamine 50mg tablets due to a labeling error where bottles labeled as Benzonatate 100mg capsules contained Benzphetamine 50mg tablets and vice versa. One physician in Alpharetta, Georgia received 13 affected bottles.
Wegmans Brand Fresh Goat Cheese (Classic Chevre with Cranberries) is being recalled because pieces of cheesecloth may be present on the exterior surface. The product was distributed in New York.
Able Sales Company is recalling Tereos Wheat Gluten containing traces of 2-chloroethanol. The affected product was distributed in Puerto Rico.
Steris Corporation is recalling 152 cases of Ultra Pure Non-Woven Sponges because the product was not approved for release for US distribution.
Higher Education Make Out Ready Vegan Lip Balm is recalled due to mislabeling of active ingredients. The label does not match the product's actual sunscreen actives.
GlaxoSmithKline is recalling 328 bottles of Tivicay (dolutegravir) tablets nationwide due to incorrect expiration date labeling. The label shows January 2027 but the correct expiration date is September 2026.
Steris Corporation is recalling 103 cases of Ultra Pure Non-Woven Sponges (Lot 202108) distributed nationwide because the product was released without FDA approval. Customers should discontinue use and contact the manufacturer.
Direct Rx is recalling Zonisamide Capsules USP 100 mg, lot 23JY2124, nationwide due to gaps in the quality control microbiology laboratory that could affect product verification.
Microbiologics Inc recalled 8 units of KWIK-STIK® plus Clostridium perfringens due to a labeling error. The affected lot (801-44-4) was distributed to laboratories in the United States and internationally.
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