Hazard

Sterility Assurance recalls

309 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility assurance recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

101–125 of 309

HighFDA (Drugs)·D-0949-2023·2023-08-09
Succinylcholine Injectable Syringes Recalled for Unvalidated Decontamination Cycles
Central Admixture Pharmacy Services recalls 26,208 succinylcholine injection syringes nationwide due to lack of validated sterilization procedures. The manufacturer lacks adequate validation data for decontamination cycles.
Product
succinylcholine 200 mg/10 mL (20 mg/mL), Syringe, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue Pheonix, AZ, NDC 72196-6011-2.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1054-2023·2023-08-09
Fentanyl Injectable Syringes Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling approximately 2,082 fentanyl injectable syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure product sterility.
Product
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0982-2023·2023-08-09
FDA Recalls Neostigmine Injectable Syringes Due to Sterility Assurance Deficiency
FDA is recalling Central Admixture Pharmacy Services' neostigmine injectable syringes due to lacking validation data for sterilization decontamination cycles, raising concerns about product sterility.
Product
neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6065-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1075-2023·2023-08-09
FDA Recalls Midazolam Injectable for Unvalidated Sterilization Process
Central Admixture Pharmacy Services Inc is recalling 621 syringes of midazolam injection because the manufacturer lacked validation data to confirm the sterilization process was effective.
Product
midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0936-2023·2023-08-02
Oxacillin for Injection recalled nationwide due to sterility concerns
Sagent Pharmaceuticals is recalling Oxacillin for Injection USP due to lack of sterility assurance. The recall affects multiple lots distributed nationwide.
Product
Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0930-2023·2023-07-26
Sodium Bicarbonate Injectable Solution Recalled for Sterility Assurance Issues
SterRx is recalling 137,304 bags of Sodium Bicarbonate in 5% Dextrose Injection nationwide because the manufacturer cannot assure the product meets sterility standards. Affected lots have expiration dates from July 2023 through February 2024.
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0669-2023·2023-05-31
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls Cardioplegia Solution (182 bags, nationwide distribution) due to lack of sterility assurance identified during FDA inspection.
Product
Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0203-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0679-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls Cardioplegia Solution (325 bags nationwide) after FDA inspection identified loss of sterility assurance. Product is used in cardiac surgery and requires prescription.
Product
Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0215-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0753-2023·2023-05-31
Lidocaine Injectable Solution Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Lidocaine 2% HCl Injectable Solution nationwide due to lack of sterility assurance following an FDA inspection. The recall affects 1,516 bags distributed across the United States.
Product
Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8091-1, code 7128580911.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0703-2023·2023-05-31
OxyTOCIN Injectable Product Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 2624 bags of oxyTOCIN due to FDA concerns about product sterility. No illnesses have been reported.
Product
oxyTOCIN 30 units added to dextrose 5%/Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6032-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0659-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Cardioplegia Solution is recalled due to sterility assurance concerns identified during an FDA inspection. The recall affects 350 bags distributed nationwide.
Product
Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-0101-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0675-2023·2023-05-31
FDA Recalls Cardioplegia Solution Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 226 bags of Cardioplegia Solution due to lack of assurance of sterility following FDA inspection. No illnesses reported.
Product
Cardioplegia Solution, Maintenance 4:1 Plasmalyte, low potassium, low K, packaged in 1047 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0211-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0697-2023·2023-05-31
Neonatal TPN Bags Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services recalled 485 bags of Neonatal TPN Starter Bag nationwide due to FDA concerns about manufacturing sterility assurance. No illnesses have been reported.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0428-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0686-2023·2023-05-31
Neonatal TPN Starter Bags Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 167 bags of neonatal TPN Starter Bag due to FDA concerns about product sterility identified during inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0408-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0721-2023·2023-05-31
Vancomycin and Dextrose Injection Sterility Recall by Central Admixture
Central Admixture Pharmacy Services recalls 10,282 bags of vancomycin in dextrose 5% nationwide after FDA inspection raised sterility assurance concerns for this injectable pharmaceutical product.
Product
vancomycin added to dextrose 5%, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6075-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0695-2023·2023-05-31
Neonatal TPN Starter Bags Recalled for Unassured Sterility
Central Admixture Pharmacy Services is recalling 135 bags of neonatal TPN starter bags distributed nationwide because the FDA found inadequate assurance of sterility during inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0425-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0674-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services recalls 208 bags of Cardioplegia Solution nationwide due to sterility assurance concerns identified during an FDA inspection.
Product
Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0210-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0699-2023·2023-05-31
Neonatal TPN Starter Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 60 Neonatal TPN Starter Bags distributed nationwide due to sterility assurance concerns identified during an FDA inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0430-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0670-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services, Inc. is recalling cardioplegia solution for lack of assurance of sterility. FDA inspection questioned the sterility of this injectable product; 241 bags were distributed nationwide.
Product
Cardioplegia Solution, Modified St Thomas Solution, HIGH POTASSIUM, HIGH SODIUM BICARBONATE, 106 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0204-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0658-2023·2023-05-31
FDA Recalls Cardioplegia Solution Due to Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 267 bags of Cardioplegia Solution after FDA inspection raised questions about sterility assurance. The prescription product was distributed nationwide.
Product
Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K, packaged in 830 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0100-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0723-2023·2023-05-31
Drug Recall: Vancomycin Injectable Lacks Sterility Assurance
Central Admixture Pharmacy Services recalls 7,632 bags of vancomycin injectable (NDC 71285-6078-1) nationwide due to FDA-identified sterility assurance deficiency.
Product
vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6078-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0740-2023·2023-05-31
FDA recalls oxytocin admixture bags for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 2,186 bags of oxytocin intravenous admixture nationwide due to lack of sterility assurance following an FDA inspection.
Product
oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8069-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0654-2023·2023-05-31
FDA Recalls Cardioplegia Solution Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance. An FDA inspection questioned sterility of 254 bags distributed nationwide.
Product
Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0719-2023·2023-05-31
Vancomycin Dextrose Injectable Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 13,772 bags of vancomycin-dextrose injectable distributed nationwide after an FDA inspection questioned its sterility assurance. No illnesses have been reported.
Product
vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6073-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0651-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (Reperfusate No Potassium) due to lack of assurance of sterility identified during FDA inspection.
Product
Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0006-1.
Category
Drug
Distribution
Distributed nationwide