Class I - Dangerous
Crystallization with subpotent out of specification assay results for chlorhexidine.
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Prescription Drugs
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Crystallization with subpotent out of specification assay results for chlorhexidine.
GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842
Genetic Edge Compounds
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.
D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1
HARDCORE FORMULATIONS
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Class I - Dangerous
Failed impurities/degradation specifications: Out of specification for a related compound C.
ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0
HARDCORE FORMULATIONS
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12
Cantrell Drug Company
Class I - Dangerous
Lack of Sterility Assurance.
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01
HOSPIRA INC, LAKE FOREST
Class I - Dangerous
Presence of Particulate Matter: Silicone oil
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-118-15
Cantrell Drug Company
Class I - Dangerous
Lack of Sterility Assurance.
Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-15
Cantrell Drug Company
Class I - Dangerous
Lack of Sterility Assurance.
Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
X-Gen Pharmaceuticals
Class I - Dangerous
Presence of Foreign Substance: potential presence of plastic particles.
Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-046-15
Cantrell Drug Company
Class I - Dangerous
Lack of Sterility Assurance.
Class I - Dangerous
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-064-15
Cantrell Drug Company
Class I - Dangerous
Lack of Sterility Assurance.
Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-45
Cantrell Drug Company
Class I - Dangerous
Lack of Sterility Assurance.
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50
HOSPIRA INC, LAKE FOREST
Class I - Dangerous
Presence of Particulate Matter: Silicone oil
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-15
Cantrell Drug Company
Class I - Dangerous
Lack of Sterility Assurance.
Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222
Cantrell Drug Company
Class I - Dangerous
Lack of Sterility Assurance.
Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.
AtHome Medical
Class I - Dangerous
GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Succinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-12
Cantrell Drug Company
Class I - Dangerous
Lack of Sterility Assurance.