Pending Recalls. FDA is conducting a pilot program seeking to expedite notifications of human drug product recalls to the public. In addition to the information about classified recalls found in the weekly Enforcement Report, the agency will include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. The information will be continue to be provided in a narrative format until FDA has decided upon the method to include it in the new Enforcement Report format. Send comments or suggestions to CDERRecall. Most of us have been there. You put on a few extra pounds maybe over the holidays or on vacation. Or maybe you just stopped working. Poisoned by plastic: Chemicals in water bottles and food packaging have been linked to infertility and birth defects. Scaremongering, or the truth? Pilot@fda. hhs. gov. Pending Recalls for the February 1. Enforcement Report. PRODUCT Indocin. 1/2. Lot 0. 17. 60. 00. Exp. 8/2. 01. 8Lot 0. Exp. 9/2. 01. 8RECALLING FIRMIroko Pharmaceuticals, LLC, Philadelphia, PA 1. REASON FOR RECALLFailed Impurities/Degradation Specifications Pending Recalls for the February 1, 2. Tommee Tippee Closer to Nature Easi-vent 260 ml/9fl oz Feeding Bottles (3-Pack). Want to lose weight fast? Pure Asian Garcinia will help you melt your body fat without changing your diet! Get your free bottle today! Daily news on food ingredients, flavours, starch and food additives. Free access to news on food science in Europe. Buy Best Value 90% HCA Garcinia Cambogia 3 pk - Best Quality Clinically Tested Pharmaceutical Grade - Best Weight Loss and Satisfaction Guarantee on Amazon.com FREE. After seeing it recommended by Dr. Oz, you might be wondering whether. Kay Ireland specializes in health, fitness and lifestyle topics. She is a support worker in the neonatal intensive care and antepartum units of her local. Pseudoephedrine Erection Ams 700 Mri with Erectile Dysfunction Doctors In New Iberia La and Best Vitamins For Erections are inability to get or keep an erection and. Help Lose Weight 3 Bottles Packaging WholesaleEnforcement Report. PRODUCTAripiprazole Tablets, 2 mg, 3. Rx only, NDC 6. 05. CODELot #: MJ7. 74. Exp 0. 4/1. 7RECALLING FIRMApotex Inc., Toronto, Canada. REASON FOR RECALLSuperpotent Drug: Product may not meet specifications throughout shelf life. PRODUCT Pantoprazole sodium for Injection 4. Rx only, NDC 5. 51. CODELot #: CPO1. 60. Exp. June 2. 01. 8RECALLING FIRMAuro. Medics Pharma LLCREASON FOR RECALLDiscoloration. PRODUCTProtonix I. V. 4. 16. 10. 0 (0. RECALLING FIRMVista. Pharm, Inc., Largo Florida. REASON FOR RECALLMicrobial Contamination of a Non- Sterile Product: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. PRODUCTPantoprazole Sodium Delayed Release Tablets USP, 4. Rx only, NDC 5. 97. CODELot Number PA2. A; Exp. 0. 4/1. 9RECALLING FIRMJubilant Cadista Pharmaceuticals, Inc., Salisbury Maryland. REASON FOR RECALLDiscoloration: Complaints received that some tablets were discolored and some were sticking together. PRODUCTCarbidopa and Levodopa Tablets USP 2. Rx only, NDC 6. 27. CODEJKP3. 99. 1A, JKP5. A 1. 1/2. 01. 7; JKP5. A 1. 2/2. 01. 7; JKR6. A 0. 7/2. 01. 8RECALLING FIRMSun Pharmaceutical Industries, Inc., Cranbury New Jersey. REASON FOR RECALLFailed Dissolution Failure. PRODUCTMidazolam Injection USP 2. L (5 mg/m. L), 5 m. L vials, 1. 0 count vials, Rx only, NDC 6. CODE6. 00. 73. 27 and 6. Exp 0. 1- 2. 01. 7RECALLING FIRMFresenius Kabi US, LLC, Lake Zurich, ILREASON FOR RECALLFailed Impurities/Degradations Specifications; 3. Pending Recalls for the July 2. Enforcement Report. PRODUCTGlipizide ER tablets, 2. Rx only, 3. 0- count bottle, NDC 0. CODELot # 3. 13. 25. Exp. Date 0. 2/2. RECALLING FIRMActavis, Inc.,Parsippany New Jersey REASON FOR RECALLFailed Dissolution Specification: exceeded specification rates for the 1. PRODUCTDivalproex Sodium Delayed- release Tablets USP, RX, 2. NDC 0. 09. 3- 7. 44. CODELot # 0. 2D1. Exp 9/2. 01. 7RECALLING FIRMTeva North America, Horsham, PAREASON FOR RECALLFailed Tablet/Capsule Specifications; out of specification for weight. Pending Recalls for the June 8, 2. Enforcement Report. PRODUCTAll Unexpired Sterile Compounded Products manufactured between 1/1/2. CODEAll Lots. RECALLING FIRMWell Care Compounding Pharmacy, Las Vegas, NVREASON FOR RECALLLack of Assurance of Sterility. Pending Recalls for the June 1, 2. Enforcement Report. PRODUCTLibrax (chlordiazepoxide HCl/clidinium bromide) capsules 5/2. Rx Only, NDC 0. 18. Chlordiazepoxide HCl/Clidinium Bromide capsules, 5/2. Rx Only, NDC 6. 86. CODELot #: 1. 4L0. P, Exp: 0. 6/1. 6 and 1. E0. 29. P Exp: 4/1. Lot #: 1. 3G0. 05. P, 1. 3G0. 10. P, Exp: 0. Lot #: 1. 3H0. 29. P, 1. 3J0. 48. P, 1. J0. 49. P, 1. 3J0. P, Exp: 0. 8/1. 7; Lot#: 1. B0. 47. P, 1. 4B0. P, 1. 4B0. 49. P,1. C0. 43. P, 1. 4C0. P, 1. 4C0. 49. P, Exp: 0. Lot #: 1. 4D0. 48. P, 1. 4D0. 53. P, 1. D0. 54. P, Exp: 0. Lot#: 1. 4G0. 42. P, 1. 4G0. 47. P, 1. G0. 49. P, Exp: 5/1. Lot#: 1. 4J0. 05. P, 1. 4J0. 06. P, 1. J0. 07. P, Exp 0. Lot#: 1. 4K1. 14. P, 1. 4K1. 15. P, 1. K1. 16. P, Exp: 0. Lot#: 1. 5B0. 08. P, 1. 58. 01. 3P, 1. B0. 21. P, 1. 5C0. P, 1. 5C0. 59. P, 1. C0. 64. P, Exp: 0. Lot#: 1. 5E0. 37. P, 1. 5E0. 38. P Exp: 0. RECALLING FIRMValeant Pharmaceuticals North America LLC, 4. Somerset Corporate Blvd, Bridgewater, NJ 0. REASON FOR RECALLFailed Impurities/Degradation Specifications; at expiry. PRODUCT Doxycycline, USP Capsules 4. Packaged in 3. 0 ct Bottles, Rx Only, NDC 6. CODE Lot# 1. 49. 60. A, Expiry: 0. 8/3. Lot #: AD9. 84. 8A, Expiry: 1. RECALLING FIRM Galderma Laboratories, L. P., Fort Worth, TX 7. REASON FOR RECALL Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing. Pending Recalls for the May 2. Enforcement Report. PRODUCTVancomycin for Injection, USP, 1. L vials, Rx only, NDC 0. CODELot #: 5. 65. A, Exp 0. 8/1/2. 01. RECALLING FIRMHospira, A Pfizer Company, Lake Forest, ILREASON FOR RECALLPresence of Particulate Matter; cardboard particles observed in solution. PRODUCTSulfacetamide Sodium Ophthalmic Solution USP 1. Sterile, Rx Only, NDC 1. CODELot 5. A1. 7A, exp 6/1. K2. 1A, exp 3/1. 7 and Lot 6. A0. 8A, exp 6/1. 7RECALLING FIRMAkorn, Inc., Lake Forest, ILREASON FOR RECALLLack of Assurance of Sterility. PRODUCTNorditropin Flexpro 3. L Injection, Rx only, NDC 0. CODELot FC7. 02. 22, exp 7/2. RECALLING FIRMNovo Nordisk Inc., Princeton, NJREASON FOR RECALLDefective Delivery System; may have a low frequency assembly fault which may result in pens block during the so- called . NJREASON FOR RECALLLabeling; product contains undeclared API; product back label does not indicate Oxybenzone (active) and Octyldodecanol (excipient)Pending Recalls for the May 1. Enforcement Report. PRODUCT: SCLEROSOL Intrapleural Aerosol Canisters (sterile talc powder 4 g.), Rx. Only, NDC 6. 32. 56- 1. CODE: 4. L0. 34, Exp May 2. RECALLING FIRM: Lymol Medical, 4 Plympton St.,Woburn, MA 0. Distributed by: Bryan Corporation, Woburn, MA 0. REASON FOR RECALL: Defective Delivery System; Defective stem valve caused leakage of the propellant in the spray canister causing no drug or an inadequate amount of the drug to be delivered. Pending Recalls for the April 2. Enforcement Report. PRODUCT5. 0% Magnesium Sulfate Injection, USP, 1. ML (0. 5 g/m. L), 2. L Single- dose vials, Hospira, Inc., Lake Forest, ILCODE4. DK, Exp 1. JUN2. 01. DK, 4. 8- 1. 29- DK, 4. DK, 4. 8- 2. 62- DK, 4. DK, Exp 1. DEC2. 01. DK, Exp 1. APR2. 01. RECALLING FIRMHospira Inc., Lake Forest, ILREASON FOR RECALLFailed p. H Specifications: confirmed out- of- specification results for p. H. PRODUCTQuelicin (Succinylcholine Chloride) Injection, USP, 2. Rx only. 2) Baclofen 5. Rx only. 3) Hydromorphone HCL 1. Baclofen 4. 60 mcg/ml Bupivacaine HCL vol. Rx only. 4) Morphine Sulfate 0. Baclofen 1. 00. 0 mcg/ml vol. Rx only. 5) Hydromorphone 1. Baclofen 4. 50 mcg/ml vol. Rx only. 6) Morphine Sulfate 9 mg/ml Sufentanil Cit 1. Bupivacaine HLC 3. Rx only. 7) Sufentanil Cit 1. Baclofen 3. 00 mcg/ml vol. Rx only. 8) Morphine Sulfate 0. Rx only. 9) Morphine Sulfate 2. Bupivacaine HCL 1. Rx only. 10) Morphine Sulfate 5. Bupivacaine HCL 2. Rx only. 11) Hydromorphone HCL 1. Bupivacaine HCL 3. Rx only. 12) Morphine Sulfate 1. Rx only. 13) Baclofen 2. Rx only Hartley Med Ctr Pharmacy (8. Hydromorphone HCL 2. Bupivacaine HCL 4. Rx only. 15) Hydromorphone HCL 2. Rx only. 16) Hydromorphone HCL 1. Fentanyl Citrate 0. Rx only. 17) Hydromorphone HCL 1. Rx only. 18) Hydromorphone HCL 2 mg/ml vol. Rx only. 19) Morphine Sulfate 1. Rx only. 20) Fentanyl Citrate 1. Baclofen 1. 50 mcg/ml Bupivacaine HCL 2. Clonidine HCL 4. 50 mcg/ml vol. Rx only. 21) Hydromorphone HCL 1 mg/ml vol. Rx only. 22) Hydromorphone HCL 2. Bupivacaine HCL 4 mg/ml vol. Rx only. 23) Hydromorphone HCL 1. Bupivacaine HCL 4 mg/ml vol. Rx only. 24) Morphine Sulfate 1. Rx only. 25) Hydromorphone HCL 7 mg/ml Bupivacaine HCL 1. Rx only. 26) Sufentanil Cit 2. Clonidine HCL 1. 60. Rx only. 27) Morphine Sulfate 2. Rx only. 28) Morphine Sulfate 0. Rx only. 29) Hydromorphone HCL 0. Rx only. 30) Sufentanil Cit 5. Clonidine HCL 1 mcg/ml Bupivacaine HCL 5 mg/ml vol. Rx only. CODEBUD: 5/3/2. RECALLING FIRMHartley Medical Center Pharmacy, Inc., Long Beach, CAREASON FOR RECALLLack of Assurance of Sterility. Pending Recalls for the February 2. Enforcement Report. PRODUCTMedicated Better Braids, La Laque (salicylic acid) Spray, 2%,1. Fl. NDC: 3. 33. 42- 0. CODE Lot #: BPA5. A; Expiry: 0. 6/2. RECALLING FIRMMacleods Pharma USA, Inc., Plainsboro, NJREASON FOR RECALL Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet. PRODUCT1) risperi. DONE ORALLY DISINTEGRATING TABLETS, 0. Ct Bottles, Rx Only. DONE ORALLY DISINTEGRATING TABLETS, 1 mg, 3. Ct Bottles, Rx Only. DONE ORALLY DISINTEGRATING TABLETS, 2 mg, 3. Ct Bottles, Rx Only. CODE1) Lot #: MP2. Expiry: 0. 2/2. 01. Lot #: MP4. 96. 5, Expiry: 0. Lot #: MP6. 91. 7, Expiry: 0. Lot #: MP2. 94. 4, Expiry: 0. Lot #: MP4. 96. 6, Expiry: 0. Lot #: MP6. 91. 8, Expiry: 0. Lot #: MP4. 96. 7, Expiry: 0. RECALLING FIRMZydus Pharmaceuticals USA Inc. Pennington, NJREASON FOR RECALLFailed Impurities/Degradation Specifications: Out of specification for a known degradant. PRODUCT Triamcinolone Diacetate Injectable Suspension, 4. L, 1. 0m. L Multi- Dose Vial for Injection. CODELot Number: 1. Do Not Use Beyond: 0. The correct value that should have been printed is 4. Units per 1/8 teaspoon. PRODUCTMidazolam HCl Syrup, 1. L, 5 m. L unit dose cups, Rx only, packaged in 2 shelf boxes, one shelf box containing 7. Cherry Brandy Flavor. CODE Lot: 9. Exp 0. 8/0. 4/1. 6RECALLING FIRM Safecor Health, LLC, Woburn, MAREASON FOR RECALLPresence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant. PRODUCT 1. 1) Syr. Spend SF, Rx Only, 5. L bottle, Rx only, NDC 5. Syr. Spend SF, Suspending Base, Grape Flavored, Rx Only, 4 L bottle, NDC 5. Syr. Spend SF, Suspending Base, Rx Only, 4 L bottle, NDC 5. CODE1) Lot #s: 1. I2. 1- U0. 1- 0. 27. I2. 1- U0. 1- 0. 26. J1. 9- U0. 5- 0. 27. Lot #s: 1. 5A0. 5- U0. G2. 9- U0. 3- 0. 25. Lot #s: 1. 5J2. 6- U0. J2. 6- U0. 5- 0. 27.
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