Prescription medicine recalls

ACME UNITED CORPORATION — Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes

CGMP Deviations

ACME UNITED CORPORATION — Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02

CGMP Deviations

ACME UNITED CORPORATION — Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.

CGMP Deviations

McKesson — UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only

Temperature Abuse.

Specialty Process Labs LLC — Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02

Subpotent Drug

Greenstone Llc — methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only

Labeling: Not Elsewhere Classified.

Amerisource Health Services LLC — Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: Ame

Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.

Teva Pharmaceuticals USA, Inc — Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only

Superpotent and Subpotent

Teva Pharmaceuticals USA, Inc — Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack

Superpotent and Subpotent

Graviti Pharmaceuticals Private Limited — Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only

Presence of Foreign Substance

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Encon Safety Products Co — AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each

cGMP deviations.

Cipla USA, Inc. — Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only

Presence of Particulate Matter.

Wizcure Pharmaa Private Limited — BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Alvogen, Inc — Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only

Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.

AvKARE — Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton

Out of specification for dissolution.

Wizcure Pharmaa Private Limited — Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Wizcure Pharmaa Private Limited — Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Wizcure Pharmaa Private Limited — CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Indus

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Glenmark Pharmaceuticals Inc., USA — Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…

Zydus Pharmaceuticals (USA) Inc — Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only

Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules