FDA Drug Recalls

December 6, 2021 · DrugView details →

Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1652-01

Edge Pharma, LLC

Lack of Assurance of Sterility

CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.

Dental Alliance Holdings LLC

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

Class IIITerminated

CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.

Dental Alliance Holdings LLC

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

December 3, 2021 · DrugView details →

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30

Akorn, Inc.

Labeling: Missing Label

CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.

Dental Alliance Holdings LLC

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34

Akorn, Inc.

Labeling: Missing Label

CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.

Dental Alliance Holdings LLC

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 Distributed in 12-pk/cases

Dental Alliance Holdings LLC

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and six boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.

Dental Alliance Holdings LLC

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409

Valgene Incorporated dba Cape Drugs

Lack of Processing Controls

CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.

Dental Alliance Holdings LLC

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409

Valgene Incorporated dba Cape Drugs

Lack of Processing Controls

Class ITerminated

Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2

Gilead Sciences, Inc.

Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.

December 2, 2021 · DrugView details →

Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920.

Torrent Pharma Inc.

Failed Dissolution Specifications

December 1, 2021 · DrugView details →

Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-159-30

Torrent Pharma Inc.

Superpotent; Hydrochlorothiazide

Class ITerminated

Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416

Aroma Release Technologies Inc

Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol

Class IIOngoing

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64

Teligent Pharma, Inc.

Superpotent Drug: Minimally superpotent

Class IOngoing

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64

Teligent Pharma, Inc.

Superpotent Drug

5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66

Pfizer Inc.

Lack of sterility assurance: bag has the potential to leak.