CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Mar 25, 2020 Prescription Drugs View Details →

Nasal Ez, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Herbal Doctor Remedies

Class I - Dangerous

CGMP Deviations: These products have been found to be misbranded as unapproved new drugs

Mar 24, 2020 Prescription Drugs View Details →

C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.

Medical Center Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Mar 13, 2020 Prescription Drugs View Details →

Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01

Lupin Pharmaceuticals

Class I - Dangerous

Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.

Apr 1, 2020 Prescription Drugs Nationwide View Details →

Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01

Par Pharmaceutical

Class I - Dangerous

Failed Impurities/Degradation Specification: Presence of unknown impurity observed.

Mar 30, 2020 Prescription Drugs View Details →

*Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 00409-1134-03.

Medical Center Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Mar 13, 2020 Prescription Drugs View Details →

C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206-0251-05.

Medical Center Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Mar 13, 2020 Prescription Drugs View Details →

C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 63323-0010-02.

Medical Center Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Mar 13, 2020 Prescription Drugs View Details →

*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.

Medical Center Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Mar 13, 2020 Prescription Drugs View Details →

Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02

Akorn

Class I - Dangerous

Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.

Mar 25, 2020 Prescription Drugs Nationwide View Details →

Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540.

Dr. Reddy's Laboratories

Class I - Dangerous

Defective Container: Recall is due to breaking and shattering of ampules upon opening

Mar 16, 2020 Prescription Drugs Nationwide View Details →

Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01.

Nostrum Laboratories

Class I - Dangerous

CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.

Mar 6, 2020 Prescription Drugs View Details →