Class II · Moderate risk Ongoing
Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India…
Reason Discoloration
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Class II · Moderate risk Ongoing
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical…
Reason Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Class II · Moderate risk Ongoing
ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628…
Reason Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Class II · Moderate risk Ongoing
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd…
Reason Presence of Particulate Matter: Particulate matter identified as glass
Class II · Moderate risk Ongoing
Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case)…
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA…
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Class II · Moderate risk Ongoing
AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA…
Reason cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand…
Class II · Moderate risk Ongoing
Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development…
Reason cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand…
Class II · Moderate risk Ongoing
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or…
Reason Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II · Moderate risk Ongoing
Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden…
Reason cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Class II · Moderate risk Ongoing
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed…
Reason Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II · Moderate risk Ongoing
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed…
Reason Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II · Moderate risk Ongoing
Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave…
Reason CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Class II · Moderate risk Ongoing
Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview…
Reason Product Mix-up
Class II · Moderate risk Terminated
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only…
Reason Lack of assurance of sterility.
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c)…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c)…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05)…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez…
Reason CGMP Deviations: Market complaints received for gritty texture (grainy)
Class II · Moderate risk Ongoing
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO…
Reason CGMP Deviations
Class I · High risk Ongoing
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota…
Reason Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc…
Reason Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved…
Class II · Moderate risk Ongoing
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health…
Reason Failed Dissolution Specifications.
Class II · Moderate risk Ongoing
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals…
Reason Failed Tablet/Capsule Specifications