Class II · Moderate risk Ongoing
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10
Reason Presence of Foreign Tablets/Capsules
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Class III · Low risk Ongoing
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder…
Reason Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe…
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe…
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class III · Low risk Ongoing
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b)…
Reason Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Class II · Moderate risk Ongoing
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For…
Reason Incorrect Product Formulation
Class III · Low risk Ongoing
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh…
Reason Cross Contamination with Other Products
Class II · Moderate risk Ongoing
Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred…
Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence…
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence…
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence…
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Ongoing
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured…
Reason Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Class II · Moderate risk Ongoing
Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL…
Reason Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Class III · Low risk Ongoing
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India…
Reason Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Class III · Low risk Ongoing
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis…
Reason Defective Container - A defect in the side-seal which allows leakage of product.
Class I · High risk Ongoing
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of…
Reason Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class II · Moderate risk Ongoing
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples…
Reason Defective container - seal not adhering to bottles
Class II · Moderate risk Ongoing
OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only…
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose…
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton…
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton…
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50…
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50…
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50…
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC…
Reason cGMP deviations