FDA recalls, February 2018: 326 published

77 different companies appear this month.

Risk classification: Class I: 32 · Class II: 275 · Class III: 19

Same month, other agencies:CPSC 24 recallsFSIS 8 recallsNHTSA 62 recalls

Recalls this month

DateProduct
February 28, 2018Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 585…D-0488-2018American Pharmaceutical Ingredients LLC
February 28, 2018Flexfrost Protein Ice Cream Coffee Flexfrost L.L.C. 622 RT 10 Whippany, NJ 07981F-0817-2018Flexfrost
February 28, 2018Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8…D-0524-2018American Pharmaceutical Ingredients LLC
February 28, 2018HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging.D-0457-2018Pharmedium Services, LLC
February 28, 2018Flexfrost Protein Ice Cream Mint Chip Flexfrost L.L.C. 622 RT 10 Whippany, NJ 07981F-0818-2018Flexfrost
February 28, 2018Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.D-0460-2018Pharmedium Services, LLC
February 28, 2018Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g…D-0526-2018American Pharmaceutical Ingredients LLC
February 28, 2018Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081…D-0512-2018American Pharmaceutical Ingredients LLC
February 28, 2018Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured …D-0427-2018Aurobindo Pharma Ltd.
February 28, 2018Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 5859…D-0533-2018American Pharmaceutical Ingredients LLC
February 28, 2018Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.D-0455-2018Pharmedium Services, LLC
February 28, 2018Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging.D-0437-2018Pharmedium Services, LLC
February 28, 2018Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-00…D-0527-2018American Pharmaceutical Ingredients LLC
February 28, 2018Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8…D-0523-2018American Pharmaceutical Ingredients LLC
February 28, 2018Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-…D-0505-2018American Pharmaceutical Ingredients LLC
February 28, 2018ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Pro…Z-0658-2018Arrow International Inc
February 28, 2018Potassium Chloride in 5% Dextrose in all strengths, all doses, and all packaging.D-0446-2018Pharmedium Services, LLC
February 28, 2018Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) …D-0494-2018American Pharmaceutical Ingredients LLC
February 28, 2018Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100m…D-0491-2018American Pharmaceutical Ingredients LLC
February 28, 2018Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M…Z-0687-2018Cosman Medical, LLC
February 28, 2018HYDROmorphone HCl Injection in all strengths, all doses, and all packaging.D-0433-2018Pharmedium Services, LLC
February 28, 2018Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.D-0440-2018Pharmedium Services, LLC
February 28, 2018Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-…D-0529-2018American Pharmaceutical Ingredients LLC
February 28, 2018Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 585…D-0537-2018American Pharmaceutical Ingredients LLC
February 28, 2018Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597…D-0504-2018American Pharmaceutical Ingredients LLC
February 28, 2018Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-…D-0501-2018American Pharmaceutical Ingredients LLC
February 28, 2018Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2)…D-0519-2018American Pharmaceutical Ingredients LLC
February 28, 2018Rocuronium Bromide in all strengths, all doses, and all packaging.D-0467-2018Pharmedium Services, LLC
February 28, 2018Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4); b…D-0532-2018American Pharmaceutical Ingredients LLC
February 28, 2018Labetalol HCl in all strengths, all doses, and all packaging.D-0447-2018Pharmedium Services, LLC
February 28, 2018Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g…D-0520-2018American Pharmaceutical Ingredients LLC
February 28, 2018Morphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.D-0436-2018Pharmedium Services, LLC
February 28, 2018Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American Ph…D-0509-2018American Pharmaceutical Ingredients LLC
February 28, 2018Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); …D-0508-2018American Pharmaceutical Ingredients LLC
February 28, 2018ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-AC…Z-0656-2018Arrow International Inc
February 28, 2018Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25…D-0513-2018American Pharmaceutical Ingredients LLC
February 28, 2018Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC 585…D-0538-2018American Pharmaceutical Ingredients LLC
February 28, 2018Methadone HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.D-0448-2018Pharmedium Services, LLC
February 28, 2018Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4); b) …D-0499-2018American Pharmaceutical Ingredients LLC
February 28, 2018Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC 58…D-0477-2018American Pharmaceutical Ingredients LLC
February 28, 2018Phenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.D-0445-2018Pharmedium Services, LLC
February 28, 2018Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b) …D-0498-2018American Pharmaceutical Ingredients LLC
February 28, 2018Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4); …D-0515-2018American Pharmaceutical Ingredients LLC
February 28, 2018Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)1…D-0493-2018American Pharmaceutical Ingredients LLC
February 28, 2018Succinylcholine Chloride in all strengths, all doses, and all packaging.D-0442-2018Pharmedium Services, LLC
February 28, 2018Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses,…D-0430-2018Pharmedium Services, LLC
February 28, 2018Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6); b…D-0534-2018American Pharmaceutical Ingredients LLC
February 28, 2018Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.D-0432-2018Pharmedium Services, LLC
February 28, 2018Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.D-0453-2018Pharmedium Services, LLC
February 28, 2018Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4); b)10…D-0514-2018American Pharmaceutical Ingredients LLC

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