FDA Recall
Completed
Historical recordClass II
Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly -sur-Seine Cedex, barcode *3421357*
by Flawless Beauty LLC
- Reason
- Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11
by Boehringer Ingelheim Roxane Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
- Published
- May 14, 2014
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
by Boehringer Ingelheim Roxane Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
- Published
- May 14, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
by Merck & Co Inc
- Reason
- Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
- Published
- May 14, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC 66582-322-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
by Merck & Co Inc
- Reason
- This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
- Published
- May 14, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30), b) 90 count blister (NDC 66582-321-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
by Merck & Co Inc
- Reason
- This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
- Published
- May 14, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 66582-320-30), b) 90 count blister (NDC 66582-320-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
by Merck & Co Inc
- Reason
- This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
- Published
- May 14, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mangiacotti - Ginger Lime Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005351, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
by Mangiacotti
- Reason
- Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
- Published
- May 14, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mangiacotti - Pomegranate Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005344, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
by Mangiacotti
- Reason
- Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
- Published
- May 14, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005337, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
by Mangiacotti
- Reason
- Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
- Published
- May 14, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005320, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
by Mangiacotti
- Reason
- Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
- Published
- May 14, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mangiacotti - Lavender Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005313, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703 .
by Mangiacotti
- Reason
- Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
- Published
- May 14, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz., 15 mL spray bottle, UPC 870678005306, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703.
by Mangiacotti
- Reason
- Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
- Published
- May 14, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.
by Wockhardt Usa Inc.
- Reason
- Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
- Published
- May 14, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.
by Apotex Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
- Published
- May 7, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) FAMILY wellness, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105. UPC: 0 32251 03394 0. C) Good Neighbor Pharmacy. Distributed By: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087. NDC: 24385-121-25. D) Pedia Care. Distributed by Medtech Products Inc., Irvington, NY 10533. UPC: 8 14832 01354 7. E) Quality Choice. Distributed by Quality Choice, Novi, MI 48376-0995. NDC: 63868-0368-04. F) Safeway. Distributed by Safeway Inc. P.O. Box 99, Pleasanton, CA 94566. NDC: 21130-152-04. G) Well at Walgreens. Distributed By: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0152-04.
by P&L Developments, LLC
- Reason
- Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
- Published
- May 7, 2014
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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