Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-065-2013 | 10-24-2012 | Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709. Package NDCs: 0173-0715-20; 0173-0715-22; 0173-0716-20; 0173-0716-22; 0173-0717-20; 0173-0717-22 | Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. | GlaxoSmithKline, LLC. / 18,676 Aerosol Units | Class III | Terminated |
| D-064-2013 | 10-24-2012 | Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20. Package NDCs: 0173-0715-20; 0173-0715-22; 0173-0716-20; 0173-0716-22; 0173-0717-20; 0173-0717-22 | Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. | GlaxoSmithKline, LLC. / 310,964 Aerosol Units | Class III | Terminated |
| D-151-2013 | 10-23-2012 | ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum SPF15, All Skin types, 1.7 FL. OZ. LIQ/50 ml (tube inside a unit carton) with UPC No. 2713179904, Code WKEM-01, and 1.5 mL foil sample packets, ESTEE LAUDER, DIST., NEW YORK, N.Y. 10022 NDC 11559-008-01 | Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled. | Estee Lauder Inc / 1.7 oz. 241,236 tubes; 1.5 mL sample size 544,548 foil packs | Class III | Terminated |
| D-370-2014 | 10-22-2012 | Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1 | Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs. | Zi Xiu Tang Success, LLC / 16126 bottles | Class I | Terminated |
| D-369-2014 | 10-22-2012 | Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 6 937000 700019 | Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs. | Zi Xiu Tang Success, LLC / 6084 bottles | Class I | Terminated |
| D-184-2013 | 10-22-2012 | HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54 Package NDCs: 0409-1555-64; 0409-1555-54 | Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag. | Hospira Inc. / 11,412 bags | Class II | Terminated |
| D-013-2013 | 10-19-2012 | Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.; NDC 52544-383-28. | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). | Watson Laboratories Inc / 30,267 cartons | Class II | Terminated |
| D-016-2013 | 10-19-2012 | Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 mg/35 mcg, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.; NDC 52544-554-28. | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). | Watson Laboratories Inc / 1,684 cartons | Class II | Terminated |
| D-017-2013 | 10-19-2012 | Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Pharma, Inc., A subsidiary of Watson Pharmaceuticals, Inc., Corona, CA 92880 USA; NDC 52544-552-28. | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). | Watson Laboratories Inc / 6,466 cartons | Class II | Terminated |
| D-014-2013 | 10-19-2012 | Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc., Parsippany, NJ 07054 USA; NDC 52544-949-28. | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). | Watson Laboratories Inc / 67,860 cartons | Class II | Terminated |
| D-015-2013 | 10-19-2012 | Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA; NDC 52544-953-28. | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). | Watson Laboratories Inc / 12,333 cartons | Class II | Terminated |
| D-044-2013 | 10-15-2012 | AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8. | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. | Valeant Pharmaceuticals / 145,650 bottles | Class III | Terminated |
| D-045-2013 | 10-15-2012 | AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0402, UPC 7 88521 12030 7. | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. | Valeant Pharmaceuticals / 619,029 tubes | Class III | Terminated |
| D-047-2013 | 10-15-2012 | AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13548 6. | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. | Valeant Pharmaceuticals / 81,319 canisters | Class III | Terminated |
| D-043-2013 | 10-15-2012 | AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair Lotion (benzoyl peroxide 10% w/v) AFCS-0303-00, and 1-count 1 oz (28 g) bottle AFSV-0305-03, Retinol Renewal Complex per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12900 3. | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. | Valeant Pharmaceuticals / 477,107 cartons | Class III | Terminated |
| D-049-2013 | 10-15-2012 | AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13546 2. | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. | Valeant Pharmaceuticals / 115,785 canisters | Class III | Terminated |
| D-046-2013 | 10-15-2012 | AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6. | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient. | Valeant Pharmaceuticals / 71,369 jars | Class III | Terminated |
| D-048-2013 | 10-15-2012 | AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9. | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. | Valeant Pharmaceuticals / 10,434 canisters | Class III | Terminated |
| D-042-2013 | 10-15-2012 | AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12008 6. | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. | Valeant Pharmaceuticals / 1,097,846 cartons | Class III | Terminated |
| D-010-2013 | 10-11-2012 | Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-5092-21. | Tablet Separation: Possibility of cracked or split coating on the tablets. | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals / 2,755 bottles | Class II | Terminated |
| D-802-2013 | 10-10-2012 | QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01 | Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg. | American Health Packaging / 19060 blister cards | Class II | Terminated |
| D-068-2013 | 10-08-2012 | Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06 | Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits. | GlaxoSmithKline, LLC. / 1,319 vials | Class II | Terminated |
| D-053-2013 | 10-06-2012 | All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com | GMP Deviations | New England Compounding Center / | Class II | Terminated |
| D-052-2013 | 10-06-2012 | All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com | Lack of Assurance of Sterility | New England Compounding Center / | Class II | Terminated |
| D-263-2013 | 10-05-2012 | Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09. | Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold. | Hospira Inc. / 136,224 flexible containers | Class I | Terminated |
| D-009-2013 | 10-05-2012 | Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz (59.15 mL), b) 8 fl.oz (236.6 mL), c) 16 fl.oz (473.2 mL), d) 32 fl.oz (946.4 mL), e) 64 fl.oz (1.89 L), and f) 1 Gal. (3.78 L), Distributed by: Earthborn Products, San Diego, CA 92103. | Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded. | Earthborn Products, Inc. / 161 gallons | Class II | Terminated |
| D-099-2013 | 10-04-2012 | Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02. Package NDCs: 0409-4713-12; 0409-4713-26; 0409-4713-02; 0409-4713-72; 0409-4713-62; 0409-4713-75; 0409-4713-65; 0409-4713-42; 0409-4713-25; 0409-4713-32; 0409-4278-16; 0409-4278-01; 0409-4279-16; 0409-4279-02; 0409-4776-10; 0409-4776-01; 0409-4282-11; 0409-4282-25; 0409-4282-01; 0409-4282-12; 0409-4282-02; 0409-4277-16; 0409-4277-01; 0409-4277-17; 0409-4277-02; 0409-4276-16; 0409-4276-01; 0409-4276-17; 0409-4276-02; 0409-4275-16; 0409-4275-01 | Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product. | Hospira, Inc. / 120,350 vials | Class II | Terminated |
| D-007-2013 | 10-03-2012 | Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 , | Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (expiration 1/2014) because of a non-conformity dissolution failure result found during routine stability testing at the 6 month test interval. | Paddock Laboratories, LLC / 2267 bottles | Class II | Terminated |
| D-056-2013 | 09-28-2012 | Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)], labeled as a) Genuine Joe Cleaning Supplies, Lemon Scent, Anti-microbial Hand Sanitizing Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured for S.P. Richards Co., 6300 Highlands Pkwy., Smyma, GA 30082, UPC 0 35255 10477 7; b) Pro Chem Lemon Aid, Hand Sanitizing Wipes, 85-count premoistened wipes per bucket, 6 buckets per case, An exclusive product of: Pro Chem, Inc., 1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004; c) Scrubs, Lemon Hand Sanitizer Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured in the U.S.A. by ITW Dymon, 805 E. Old 56 Highway, Olathe, KS 66061, UPC 7 64769 92991 9. | CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt. | ITW Dymon / a) 216 cases; b) 75 cases; c) 29 cases | Class III | Terminated |
| D-097-2013 | 09-27-2012 | CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed by: Genentech USA, Inc., South San Francisco, CA 94080. | Short Fill: some bottles contained less than 120-count per labeled claim. | Genentech, Inc. / 1128 bottles | Class III | Terminated |
| D-0296-2015 | 09-27-2012 | ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02 Package NDCs: 63323-373-00; 63323-373-02; 63323-374-20 | Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. | Fresenius Kabi USA, LLC / 184,550 Vials | Class II | Terminated |
| D-0295-2015 | 09-27-2012 | MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25. Package NDCs: 63323-411-22; 63323-411-27; 63323-411-15; 63323-411-12; 63323-411-18; 63323-411-25; 63323-411-13; 63323-411-10; 63323-412-18; 63323-412-25; 63323-412-03; 63323-412-02; 63323-412-06; 63323-412-05; 63323-412-13; 63323-412-10 | Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. | Fresenius Kabi USA, LLC / 101,200 Vials | Class II | Terminated |
| D-0297-2015 | 09-27-2012 | CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-044-01. Package NDCs: 63323-044-00; 63323-044-01 | Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. | Fresenius Kabi USA, LLC / 240,550 Vials | Class II | Terminated |
| D-059-2013 | 09-27-2012 | Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05 | Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg. | Dr. Reddy's Laboratories, Inc. / 1512 bottles | Class II | Terminated |
| D-113-2013 | 09-26-2012 | Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / N/A | Class II | Terminated |
| D-121-2013 | 09-26-2012 | Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / 3,321 vials | Class II | Terminated |
| D-117-2013 | 09-26-2012 | Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / 165 vials | Class II | Terminated |
| D-115-2013 | 09-26-2012 | Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / 2747 vials | Class II | Terminated |
| D-109-2013 | 09-26-2012 | Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA | Non-Sterility | New England Compounding Center / 9062 vials | Class I | Terminated |
| D-124-2013 | 09-26-2012 | Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / 56,655 vials | Class II | Terminated |
| D-116-2013 | 09-26-2012 | Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / 20 vials | Class II | Terminated |
| D-122-2013 | 09-26-2012 | Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / 8919 vials | Class II | Terminated |
| D-118-2013 | 09-26-2012 | Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / 10,865 vials | Class II | Terminated |
| D-119-2013 | 09-26-2012 | Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / 7055 vials | Class II | Terminated |
| D-114-2013 | 09-26-2012 | Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / N/A | Class II | Terminated |
| D-110-2013 | 09-26-2012 | Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA | Non-Sterility | New England Compounding Center / 5130 vials | Class I | Terminated |
| D-123-2013 | 09-26-2012 | Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / 54 vials | Class II | Terminated |
| D-120-2013 | 09-26-2012 | Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / N/A | Class II | Terminated |
| D-111-2013 | 09-26-2012 | Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA | Non-Sterility | New England Compounding Center / 3822 vials | Class I | Terminated |
| D-108-2013 | 09-26-2012 | Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA | Non-Sterility | New England Compounding Center / 23,897 vials | Class I | Terminated |
| D-112-2013 | 09-26-2012 | Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / N/A | Class II | Terminated |
| D-062-2013 | 09-21-2012 | Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | American Enterprises LLC dba Sterling Gelatin / 750 kgs | Class II | Terminated |
| D-058-2013 | 09-21-2012 | Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05. | Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets. | Watson Laboratories Inc / 4,874 bottles | Class I | Terminated |
| D-1686-2012 | 09-21-2012 | 5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). | Baxter Healthcare Corp. / 753,941 containers | Class II | Terminated |
| D-1689-2012 | 09-21-2012 | 0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). | Baxter Healthcare Corp. / 897,496 containers | Class II | Terminated |
| D-1690-2012 | 09-21-2012 | Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). | Baxter Healthcare Corp. / 55,664 containers | Class II | Terminated |
| D-1687-2012 | 09-21-2012 | 10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03 | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). | Baxter Healthcare Corp. / 2,976 containers | Class II | Terminated |
| D-1688-2012 | 09-21-2012 | 5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03 | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). | Baxter Healthcare Corp. / 5,064 containers | Class II | Terminated |
| D-087-2013 | 09-20-2012 | Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01 | Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery). | Genentech Inc / 10,306 syringes | Class II | Terminated |
| D-088-2013 | 09-20-2012 | Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01 | Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery). | Genentech Inc / 12,791 syringes | Class II | Terminated |
| D-148-2013 | 09-20-2012 | SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product Forumulated and Distributed By: Globe All Wellness, LLC Hollywood, FL 33020 www.diet66.com Inquires Call 877.842.9873 | Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug. | Globe All Wellness, LLC / 40,400 bottles | Class I | Terminated |
| D-008-2013 | 09-20-2012 | Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33 Package NDCs: 0781-5283-06; 0781-5283-64; 0904-5878-33 | Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2) | Sandoz Incorporated / 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons | Class III | Terminated |
| D-035-2013 | 09-17-2012 | UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403 | Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification. | DermaCare, Inc. / 43,272 bottles | Class II | Terminated |
| D-034-2013 | 09-17-2012 | UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403 | Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification. | DermaCare, Inc. / 25,956 bottles | Class II | Terminated |
| D-1678-2012 | 09-12-2012 | Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92 | Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing. | Sandoz Incorporated / 41,761bottles. | Class III | Terminated |
| D-1677-2012 | 09-12-2012 | Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92, | Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing. | Sandoz Incorporated / 43,060 x 90 count bottles | Class III | Terminated |
| D-057-2013 | 09-10-2012 | HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21 | Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals / 14,445 bottles | Class I | Ongoing |
| D-061-2013 | 09-06-2012 | Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7. | CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG. | Church & Dwight Inc / 42,768 pumps | Class II | Terminated |
| D-105-2013 | 09-05-2012 | Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom | Lack of Assurance of Sterility; container closure issues with the bulk batch. | F. Hoffmann-LaRoche Ltd. / 42010 vials | Class II | Terminated |
| D-032-2013 | 09-04-2012 | DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1. | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 17,136 bottles | Class II | Terminated |
| D-026-2013 | 09-04-2012 | Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative/Supplement, a)160 capsules per bottle (item #503663), and b) 320 capsules per bottle (Item #586143), Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616, www.walgreens.com, a) UPC 3-11917-08151-9, b) UPC 3-11917-07658-4 | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 56,808 bottles | Class II | Terminated |
| D-025-2013 | 09-04-2012 | Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regularity/Fiber Supplement, 160 capsules per bottle, Distributed by: Target Corp., Minneapolis, MN 55403, Made in USA, NDC 11673-059-87, UPC 3-68163-11926-8. | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 48,120 bottles | Class II | Terminated |
| D-030-2013 | 09-04-2012 | Premier Value Fiber Capsules, Fiber Capsules, 100% Natural Psyllium Fiber, Relieves Constipation, Restores Regularity, 160 Capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL 33431, UPC0-40986-01703-2 | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 1,440 bottles | Class II | Terminated |
| D-029-2013 | 09-04-2012 | Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Supplement, Fiber Laxative for Regularity, 400 capsules per bottle, Distributed by: SAM'S West, Inc., Bentonville, AR 72716, UPC 0-78742-00524-9. | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 46,104 bottles | Class II | Terminated |
| D-022-2013 | 09-04-2012 | CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Capsules per bottle, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895 www.cvs.com UPC 0-50428-07739-9 | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 16,848 bottles | Class II | Terminated |
| D-031-2013 | 09-04-2012 | Premier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL, UPC 8-40986-01987-6 | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 96 bottles | Class II | Terminated |
| D-027-2013 | 09-04-2012 | Wal-Mucil Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psyllium Seed Husk, Calcium/Dietary Fiber Supplement, 240 Capsules per bottle, Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616 www.walgreens.com, NDC 0363-0128-24, UPC 3-11917-07656-0. | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 7,608 bottles | Class II | Terminated |
| D-024-2013 | 09-04-2012 | Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation, Restores Regularity, 100 capsules per bottle, Distributed by: Cardinal Health, Dublin, OH 43017 www.myleader.com, NDC 37205-372-78, UPC 0-96295-11222-1. | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 2,988 bottles | Class II | Terminated |
| D-023-2013 | 09-04-2012 | Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber Supplement, 160 capsules per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 68163-119-60, UPC 6-81131-77922-7. | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 183,141 bottles | Class II | Terminated |
| D-021-2013 | 09-04-2012 | Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fiber Laxative, 100 capsules per bottle, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, KS 06106, UPC 0-70038-63439-3 | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 2160 bottles | Class II | Terminated |
| D-028-2013 | 09-04-2012 | Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules per bottle, Distributed by: BJWC, 25 Research Drive, Westborough, MA 01581, Made in USA, UPC 4-00016-27053-2. | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 3,552 bottles | Class II | Terminated |
| D-1683-2012 | 09-04-2012 | Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30 | Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength. | Apace KY LLC / 81,516 bottles | Class III | Terminated |
| D-922-2013 | 08-31-2012 | 0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23 | Presence of Particulate Matter; product may contain fibrous material | Hospira Inc. / 264,432 bags | Class I | Terminated |
| D-012-2013 | 08-29-2012 | BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 Diluent manufactured by: Luitpold Pharmaceuticals, Inc. Shirley, NY 11967 Distributed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA Made in USA NDC 0015-3012-18 NDC 0015-3012-60 | Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot. | Bristol-myers Squibb Company / 31,481 kits | Class I | Terminated |
| D-1685-2012 | 08-29-2012 | Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25; 0409-1511-97; 0409-1511-98; 0409-0501-97; 0409-0501-98; 0409-0010-97; 0409-0010-98 | Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection. | Hospira Inc. / 148,630 vials | Class II | Terminated |
| D-308-2013 | 08-28-2012 | Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12 Package NDCs: 0409-3814-11; 0409-3814-12; 0409-3815-11; 0409-3815-12 | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial | Hospira Inc. / 26,100 vials | Class II | Terminated |
| D-309-2013 | 08-28-2012 | Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12 Package NDCs: 0409-3213-11; 0409-3213-12 | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Hospira Inc. / 172,350 vials | Class II | Terminated |
| D-1691-2012 | 08-28-2012 | Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947 | Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol | Dispensing Solutions, Inc / 18 Inhalers | Class II | Terminated |
| D-129-2013 | 08-28-2012 | I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031 | Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use. | James G. Cole, Inc. / 253 bottles | Class II | Terminated |
| D-063-2013 | 08-27-2012 | Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish) | Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug. | Samantha Lynn, Inc / 25,888 Boxes | Class I | Terminated |
| D-051-2013 | 08-23-2012 | Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30 | Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules." | Stat Rx USA / 5 bottles | Class III | Terminated |
| D-328-2013 | 08-23-2012 | Mojo Nights for Her, 1 capsule, UPC 7 18122 12133 5, Distributed By: Mojo Health Lauderhill, FL 33351 | Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs. | Evol Nutrition / 1000 blister packs (total both products) | Class I | Terminated |
| D-327-2013 | 08-23-2012 | Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351 | Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs. | Evol Nutrition / 1000 blister packs (total both products) | Class I | Terminated |
| D-073-2013 | 08-23-2012 | Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0 Manufactured for : Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 Manufactured by: DRAXIS Specialty Pharmaceuticals Inc., Quebec, Canada. NDC # 55566-1501-0 is assigned to the vial of NOVAREL and is displayed on the vial label. NDC # 55566-1501-1 is assigned to the unit of sale, which is a carton containing 1 vial of NOVAREL and 1 vial of diluent along with the insert. NDC # 55566-1501-1 is displayed on the unit of sale and is the item subject to recall. | Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products. | Ferring Pharmaceuticals Inc / 146,867 Vials | Class III | Terminated |
| D-060-2013 | 08-21-2012 | Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90 Package NDCs: 63304-828-90; 63304-828-05; 63304-827-90; 63304-827-05; 63304-829-90; 63304-829-05; 63304-830-90; 63304-830-05 | Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg. | Ranbaxy Inc. / 32,208 bottles | Class II | Terminated |
| D-003-2013 | 08-21-2012 | Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc. | Crystallization: Presence of crystals of Nimodipine within the capsule solution. | Caraco Pharmaceutical Laboratories Ltd. / a) 2424 Cartons b) 2675 Cartons | Class II | Terminated |
| D-134-2013 | 08-17-2012 | Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03 | Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging. | Axcentria Pharmaceuticals LLC / 17,679 bottles | Class III | Terminated |
| D-1660-2012 | 08-15-2012 | Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04, | Subpotent; fluocinolone acetonide. | Galderma Laboratories, L.P. / 17,160 bottles | Class III | Terminated |
| D-020-2013 | 08-15-2012 | HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1312-30, Barcode (01) 1 030409 131230 9 (carton), (01) 0 030409 131230 2 (cartridge unit). Package NDCs: 0409-2552-11; 0409-2552-01; 0409-3356-11; 0409-3356-01; 0409-2540-11; 0409-2540-01; 0409-3365-11; 0409-3365-01; 0409-3365-10; 0409-1283-03; 0409-1283-31; 0409-1312-03; 0409-1312-30; 0409-1304-03; 0409-1304-31 | Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume. | Hospira Inc. / 216,880 cartridge units | Class I | Terminated |
| D-095-2013 | 08-14-2012 | Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543, by Hollister-Stier Laboratories LLC, Spokane Washington 99207, NDC 0270-0083-20. Package NDCs: 0270-0083-20 | Presence of Particulate Matter; potential for charcoal particulates | Bracco Diagnostic Inc / 196,280 Vials | Class III | Terminated |
