Class II · Moderate risk Ongoing
FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl…
Reason Chemical contamination: Presence of benzene
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Class II · Moderate risk Ongoing
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a)…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industrial Eye…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL)…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals…
Reason Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Class I · High risk Ongoing
Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan…
Reason Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Class II · Moderate risk Ongoing
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals…
Reason Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton…
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan…
Reason Failed Dissolution Specifications
Class III · Low risk Ongoing
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate…
Reason Failed Tablet/Capsule Specifications
Class II · Moderate risk Ongoing
MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source…
Reason Stability Data Does Not Support Expiry Date.
Class II · Moderate risk Ongoing
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
Reason Stability Data Does Not Support Expiry Date.
Class II · Moderate risk Ongoing
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland…
Reason Stability Data Does Not Support Expiry Date.
Class III · Low risk Ongoing
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence…
Reason Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual…
Class III · Low risk Ongoing
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India…
Reason Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual…
Class II · Moderate risk Ongoing
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major…
Reason Defective container; inadequately sealed blister packaging.