DrugNov 25, 2015
Downing Labs DMAE Dimethylaminoethanol Injection, 100mg/mL, 30mL vial recall — FDA D-0374-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
10,690drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 281
10,690 detailed records are currently available in this category.
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential Testosterone Cypionate 200 mcg/mL in Sesame Oil recall — FDA D-328-2016
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential HCG 1000 U/ LIDO 0.2%/mL Injection recall — FDA D-307-2016
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
Downing Labs Co-Enzyme Q-10 Injectable, 20mg/mL, 10mL vial recall — FDA D-0346-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Downing Labs Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial recall — FDA D-0380-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential Sermorelin 9 mg/10 mL SUB-Q* Injection recall — FDA D-324-2016
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
US Compounding Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use recall — FDA D-0258-2016
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class IIFDA: TerminatedUS Compounding Inc.
DrugNov 25, 2015
Downing Labs TNPDR Injection Buffered, 30mL vial recall — FDA D-0362-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Downing Labs Magnesium Sulfate Injectable, 14.28%, 7mL vial recall — FDA D-0360-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Akorn Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and recall — FDA D-0295-2016
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing."…
Class IIIFDA: TerminatedAkorn, Inc.
DrugNov 25, 2015
US Compounding Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution recall — FDA D-0294-2016
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class IIFDA: TerminatedUS Compounding Inc.
DrugNov 25, 2015
Downing Labs Pyridoxine Injection, 100 mg/mL, 30mL vial recall — FDA D-0373-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
US Compounding Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical recall — FDA D-0274-2016
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class IIFDA: TerminatedUS Compounding Inc.
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential HCG 10,000 Units/mL Injection recall — FDA D-311-2016
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
Downing Labs EDTA Disodium Injectable, 150mg/mL, 100mL vial recall — FDA D-0340-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Downing Labs Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial recall — FDA D-0377-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
US Compounding Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM recall — FDA D-0282-2016
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class IIFDA: TerminatedUS Compounding Inc.
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential HCG 1000 Units/mL SUB-Q Injection recall — FDA D-306-2016
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
Downing Labs Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial recall — FDA D-0381-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential TRIMIX #1 Injection, 4.2 mL vials recall — FDA D-332-2016
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
Downing Labs EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial recall — FDA D-0357-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Downing Labs Piracetam Injection, 200mg/mL,10mL vial recall — FDA D-0372-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
US Compounding Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or recall — FDA D-0250-2016
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class IIFDA: TerminatedUS Compounding Inc.
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential LIPO-B Special Injection,12 mL vials recall — FDA D-313-2016
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
How to use this drug recall index
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.