Mckesson Medical-Surgical Inc. Corporate Office recalls Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured…
cGMP Deviations: Temperature excursion
Read the official notice →- Date
- 2024-12-18
- Country
- United States
- Brand
- Mckesson Medical-Surgical Inc. Corporate Office
- Product
- Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by…
- Classification
- Class II
- Units
- Virgina
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Mckesson Medical-Surgical Inc. Corporate Office recalls
- 2025-07-30
USMckesson Medical-Surgical Inc. Corporate Office recalls EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by:…
CGMP Deviations; potential temperature excursions due to transit delays
FDA · DrugMckesson Medical-Surgical Inc. Corporate OfficeWithin the U.S - OH, VA, FL.Official notice →- 2025-06-04
- US
Mckesson Medical-Surgical Inc. Corporate Office recalls SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an…
FDA · DeviceMckesson Medical-Surgical Inc. Corporate OfficeUS Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR,…Official notice → - 2025-05-07
- US
Mckesson Medical-Surgical Inc. Corporate Office recalls Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only,…
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products…
FDA · DrugMckesson Medical-Surgical Inc. Corporate OfficeDistributed to Medical Facilities in MS and FL.Official notice → - 2024-10-30
- US
Mckesson Medical-Surgical Inc. Corporate Office recalls Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended…
The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25¿C. This may lead to delay in patients' results.
FDA · DeviceMckesson Medical-Surgical Inc. Corporate OfficeUS Nationwide distribution in the state of DC.Official notice → - 2024-10-02
- US
Mckesson Medical-Surgical Inc. Corporate Office recalls Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb,…
Temperature abuse: Products exposed to improper temperature above drug label specifications.
FDA · DrugMckesson Medical-Surgical Inc. Corporate OfficeProduct was distributed to two medical facilities in MD and VA.Official notice → - 2024-06-19
- US
Mckesson Medical-Surgical Inc. Corporate Office recalls Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS…
Quarantined product was inadvertently distributed
FDA · DeviceMckesson Medical-Surgical Inc. Corporate OfficeUS Nationwide distribution in the state of NJ.Official notice →
Other drugs & medical recalls in the United States
- 2024-12-18
- US
Ascend Laboratories, LLC recalls Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend…
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
- US
Viatris Inc recalls Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC…
Superpotent Drug and Subpotent Drug: potency failures obtained
- US
Dr. Reddy's Laboratories, Inc. recalls Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc.,…
Failed Impurities/Degradation Specifications
- US
LNK International, Inc. recalls Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg,…
CGMP Deviations: Released product should have been rejected.
FDA · DrugLNK International, Inc.Product was distributed to 1 wholesale retail customer who may have further…Official notice → - US
FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad,…
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
- US
Biocompatibles UK, Ltd. recalls Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer…
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).