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D-0439-2022 Class II Terminated

Recalled by Edge Pharma, LLC — Colchester, VT

FDA drug recall D-0439-2022 was initiated by Edge Pharma, LLC on December 6, 2021 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated June 7, 2023). Affected quantity: 353 jars.

Recall Details

Product Type: Drugs
Report Date: February 2, 2022
Initiation Date: December 6, 2021
Termination Date: June 7, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 353 jars

Product Description

Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Container For Topical Oral Use,Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0790-10

Reason for Recall

CGMP Deviations

Distribution Pattern

nationwide

Code Information

07-2021-20@7 01-16-2022, 08-2021-11@6 02-07-2022, 08-2021-31@11 02-01-2022, 09-2021-14@11 02-01-2022, 09-2021-21@6 02-01-2022 & 10-2021-12@4 04-10-2022.

Other recalls by Edge Pharma, LLC

D-0399-2022 Class II — Dexamethasone sodium phosphate, sterile otic solution for injection Preservative (December 6, 2021)
D-0402-2022 Class II — Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservativ (December 6, 2021)
D-0446-2022 Class II — Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single D (December 6, 2021)
D-0415-2022 Class II — Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe (December 6, 2021)
D-0444-2022 Class II — Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multip (December 6, 2021)
D-0434-2022 Class II — Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per v (December 6, 2021)
D-0436-2022 Class II — LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Cont (December 6, 2021)
D-0420-2022 Class II — Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per d (December 6, 2021)
D-0403-2022 Class II — Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL (December 6, 2021)
D-0419-2022 Class II — Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preserva (December 6, 2021)