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-0353-2017 | 09-21-2016 | Dexamethasone Sodium Phosphate 200 mg/mL, Injectable, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 15 vials | Class II | Terminated |
| D-0370-2017 | 09-21-2016 | MIC/B-COMP/(M)/CHROM/CARN, 20 mg/40 mg/50 mg/25 mcg/25 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 933 vials | Class II | Terminated |
| D-0363-2017 | 09-21-2016 | Inositol/Choline/B-Complex+Leucine+CARN+CHROM+LIDO (LipoLean), Injectable, 30 mL vial, Compounded by Wells Pharmacy. Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 433 vials | Class II | Terminated |
| D-0328-2017 | 09-21-2016 | ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 250 mg/mL 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 157 vials | Class II | Terminated |
| D-0372-2017 | 09-21-2016 | MIC/B-COMP+CARN+LIDO, 15 mg/30 mg/30 mg/85 mg/20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 1716 vials | Class II | Terminated |
| D-0354-2017 | 09-21-2016 | Dexamethasone Sodium Phosphate 24 mg/mL (2.4%), Injectable, 2 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 16 vials | Class II | Terminated |
| D-0342-2017 | 09-21-2016 | B-complex + Vit C 20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 180 vials | Class II | Terminated |
| D-0344-2017 | 09-21-2016 | Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 44 vials | Class II | Terminated |
| D-0364-2017 | 09-21-2016 | Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 189 vials | Class II | Terminated |
| D-0331-2017 | 09-21-2016 | Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 1,968 vials | Class II | Terminated |
| D-0389-2017 | 09-21-2016 | Sermorelin Acetate/GHRP (2) & (6) 9 mg/3.15 mg/3.15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 3,089 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0415-2017 | 09-21-2016 | Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 9 vials and b) 78 vials, c) 210 vials | Class II | Terminated |
| D-0330-2017 | 09-21-2016 | QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 1,312 vials and b) 3,354 vials | Class II | Terminated |
| D-0350-2017 | 09-21-2016 | Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 1,638 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0421-2017 | 09-21-2016 | Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 335 vials | Class II | Terminated |
| D-0332-2017 | 09-21-2016 | MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable, 30 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 308 vials | Class II | Terminated |
| D-0373-2017 | 09-21-2016 | MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 4 vials | Class II | Terminated |
| D-0327-2017 | 09-21-2016 | Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 694 vials b) 389 vials c) 695 vials d) 5193 vials | Class II | Terminated |
| D-0351-2017 | 09-21-2016 | Chorionic Gonadotropin Lyophilized, 20,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 908 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0371-2017 | 09-21-2016 | MIC/BCOMP+CAR+ARG+CHR+LID 12.5 mg/25 mg/25 mg/25 mg/12.5 mg/0.2 mg/20 mg/mL Injectable, a) 10 mL and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 511 vials | Class II | Terminated |
| D-0341-2017 | 09-21-2016 | Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network, LLC, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 30 vials | Class II | Terminated |
| D-0368-2017 | 09-21-2016 | MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 633 vials | Class II | Terminated |
| D-0014-2017 | 09-20-2016 | Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0010-2017 | 09-20-2016 | Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0012-2017 | 09-20-2016 | Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0017-2017 | 09-20-2016 | Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0011-2017 | 09-20-2016 | Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0016-2017 | 09-20-2016 | Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0013-2017 | 09-20-2016 | Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0015-2017 | 09-20-2016 | Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0018-2017 | 09-20-2016 | Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0128-2017 | 09-19-2016 | Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Wells Pharmacy Network, LLC / 358 pellets | Class II | Terminated |
| D-0126-2017 | 09-19-2016 | Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Wells Pharmacy Network, LLC / 690 pellets | Class II | Terminated |
| D-0129-2017 | 09-19-2016 | Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Wells Pharmacy Network, LLC / 322 pellets | Class III | Terminated |
| D-0131-2017 | 09-19-2016 | Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Wells Pharmacy Network, LLC / 318 pellets | Class II | Terminated |
| D-0127-2017 | 09-19-2016 | Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Wells Pharmacy Network, LLC / 1 pellet | Class III | Terminated |
| D-0130-2017 | 09-19-2016 | Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Wells Pharmacy Network, LLC / 301 pellets | Class III | Terminated |
| D-0132-2017 | 09-19-2016 | Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Wells Pharmacy Network, LLC / 353 pellets | Class III | Terminated |
| D-0097-2017 | 09-16-2016 | Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50. Package NDCs: 0409-1559-18; 0409-1559-10; 0409-1559-19; 0409-1559-30; 0409-1560-18; 0409-1560-10; 0409-1560-19; 0409-1560-29; 0409-1582-18; 0409-1582-10; 0409-1582-19; 0409-1582-29; 0409-1587-50; 0409-1610-50; 0409-1746-70; 0409-1746-10; 0409-1746-71; 0409-1746-30; 0409-1749-70; 0409-1749-10; 0409-1749-71; 0409-1749-29; 0409-1752-50; 0409-1755-50; 0409-2510-01; 0409-2510-25; 0409-7535-01; 0409-7535-25; 0409-1250-01; 0409-1250-25; 0409-5010-01; 0409-5010-25; 0409-1530-01; 0409-1530-25; 0409-0525-01; 0409-0525-25; 0409-7510-01; 0409-7510-25; 0409-2253-01; 0409-2253-25 | Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency. | Hospira Inc., A Pfizer Company / 4768 vials | Class II | Terminated |
| D-0096-2017 | 09-16-2016 | Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50. Package NDCs: 0409-1559-18; 0409-1559-10; 0409-1559-19; 0409-1559-30; 0409-1560-18; 0409-1560-10; 0409-1560-19; 0409-1560-29; 0409-1582-18; 0409-1582-10; 0409-1582-19; 0409-1582-29; 0409-1587-50; 0409-1610-50; 0409-1746-70; 0409-1746-10; 0409-1746-71; 0409-1746-30; 0409-1749-70; 0409-1749-10; 0409-1749-71; 0409-1749-29; 0409-1752-50; 0409-1755-50; 0409-2510-01; 0409-2510-25; 0409-7535-01; 0409-7535-25; 0409-1250-01; 0409-1250-25; 0409-5010-01; 0409-5010-25; 0409-1530-01; 0409-1530-25; 0409-0525-01; 0409-0525-25; 0409-7510-01; 0409-7510-25; 0409-2253-01; 0409-2253-25 | Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency. | Hospira Inc., A Pfizer Company / 15 vials | Class II | Terminated |
| D-1528-2016 | 09-15-2016 | PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91 Package NDCs: 0046-1101-81; 0046-1102-81; 0046-1102-91; 0046-1102-52; 0046-1104-81; 0046-1104-91; 0046-1100-81; 0046-1100-91; 0046-1100-52; 0046-1103-81 | Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17. | Pfizer Inc. / 1,316 bottles (1,316,000 tablets) | Class III | Terminated |
| D-1527-2016 | 09-15-2016 | Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08805, NDC 63739-669-10 | Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry). | Mckesson Packaging Services / 3,492 unit cartons of 10 x 10 blister cards | Class III | Terminated |
| D-0095-2017 | 09-13-2016 | mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01. | Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life. | Teva Pharmaceuticals USA / 11,214 vials | Class III | Terminated |
| D-0007-2017 | 09-13-2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86 Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13; 3473357378 | Failed Dissolution Specifications | Sun Pharmaceutical Industries, Inc. / 31,762 bottles | Class III | Terminated |
| D-0116-2017 | 09-13-2016 | Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7 Package NDCs: 51672-1271-1; 51672-1271-2; 51672-1271-3; 51672-1271-7; 51672-1270-1; 51672-1270-2; 51672-1270-3; 51672-1270-7; 51672-1261-1; 51672-1261-2; 51672-1261-3 | Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation). | Taro Pharmaceuticals, Inc. / 15,576 units | Class II | Terminated |
| D-0117-2017 | 09-13-2016 | Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1271-7 Package NDCs: 51672-1271-1; 51672-1271-2; 51672-1271-3; 51672-1271-7; 51672-1270-1; 51672-1270-2; 51672-1270-3; 51672-1270-7; 51672-1261-1; 51672-1261-2; 51672-1261-3 | Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation). | Taro Pharmaceuticals, Inc. / 6,756 units | Class II | Terminated |
| D-0003-2017 | 09-12-2016 | Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK | Lack of Assurance of Sterility; medication was sterilized with a recalled filter | The Apothecary Shoppe LLC / 455 mL total volume | Class II | Terminated |
| D-0004-2017 | 09-12-2016 | Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK | Lack of Assurance of Sterility; medication was sterilized with a recalled filter | The Apothecary Shoppe LLC / 247.5 mL total volume | Class II | Terminated |
| D-0488-2017 | 09-12-2016 | Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules, 90 count bottles, Rx only, Moore's Pharmacy Compounding, Corpus Christi, TX | Superpotent Drug and Subpotent Drug; potency failures obtained | MOORE'S COMPOUNDING PHARMACY / 90 capsules | Class II | Terminated |
| D-0002-2017 | 09-12-2016 | Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK | Lack of Assurance of Sterility; medication was sterilized with a recalled filter | The Apothecary Shoppe LLC / 419 mL total | Class II | Terminated |
| D-0164-2017 | 09-09-2016 | Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002 | Microbial Contamination of Non-Sterile Product | Cadila Pharmaceuticals Limited / 6.0kg | Class II | Terminated |
| D-0424-2017 | 09-09-2016 | Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34 Package NDCs: 0025-1451-60; 0025-1461-34; 0025-1461-60; 0025-1461-31 | Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months | Pfizer Inc. / 1,706 cartons | Class III | Terminated |
| D-1550-2016 | 09-08-2016 | Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx only, Manufactured by: Dr. Reddy's Laboratories, Inc., 200 Somerset Corporate Blvd Floor 7, Bridgewater, NJ 08807, NDC 63739-0555-10 | Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules. | Mckesson Packaging Services / 181 unit cartons of 10 x 10 blister cards | Class III | Terminated |
| D-0217-2017 | 09-08-2016 | GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15 | Defective delivery system: detached needles on the syringe in the kit. | Novo Nordisk Inc / 71,215 kits | Class I | Terminated |
| D-0001-2017 | 09-07-2016 | Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01 Package NDCs: 60635-118-01; 60635-018-01; 60635-133-01; 60635-123-01 | Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack | Biocompatibles U.K., Ltd. / 3,254 administration packs | Class III | Terminated |
| D-0006-2017 | 09-02-2016 | Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10 Package NDCs: 59417-101-10; 59417-102-10; 59417-103-10; 59417-104-10; 59417-105-10; 59417-106-10; 59417-107-10; 59417-115-01; 59417-116-01; 59417-117-01; 59417-118-01; 59417-119-01; 59417-120-01 | Presence of Foreign Tablets/Capsules | Shire / 7,680 bottles (768,000 capsules) | Class III | Terminated |
| D-0499-2017 | 09-02-2016 | EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20 | Lack of assurance of sterility | United Exchange Corporation / 190,710 bottles | Class II | Terminated |
| D-0496-2017 | 09-02-2016 | EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20 | Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples. | United Exchange Corporation / 46,080 bottles | Class I | Terminated |
| D-0214-2017 | 09-02-2016 | Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10. | Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. | VIRTUS PHARMACEUTICALS OPCO II L / 24,444 bottles | Class I | Terminated |
| D-0213-2017 | 09-02-2016 | Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10. | Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. | VIRTUS PHARMACEUTICALS OPCO II L / 10,572 bottles | Class I | Terminated |
| D-0497-2017 | 09-02-2016 | Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0536-1083-97 | Lack of assurance of sterility | United Exchange Corporation / 112,320 bottles | Class II | Terminated |
| D-0212-2017 | 09-02-2016 | Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10. | Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. | VIRTUS PHARMACEUTICALS OPCO II L / 94,643 bottles | Class I | Terminated |
| D-0498-2017 | 09-02-2016 | Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp., 17211 Valley View Ave., Cerritos, CA 90703, Made in Korea, UPC Code: 780707005828 | Lack of assurance of sterility | United Exchange Corporation / 77,184 bottles | Class II | Terminated |
| D-0704-2017 | 09-01-2016 | Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412 USA NDC: 0024-5862-01 Package NDCs: 0024-5862-01 | Labeling: Incorrect or Missing Package Insert | Sanofi-Aventis U.S. LLC / 2133 vials | Class III | Terminated |
| D-0118-2017 | 08-30-2016 | Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30. | Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17. | Actavis Laboratories, FL, Inc. / 15,984 bottles | Class III | Ongoing |
| D-0098-2017 | 08-29-2016 | ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81 Package NDCs: 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78 | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 3,858 prescription packs (115,680 capsules) | Class III | Terminated |
| D-1487-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-898-32; Blister NDC 68084-898-33 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 126 cartons | Class II | Terminated |
| D-1486-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-815-25; Blister NDC 68084-815-95 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 834 cartons | Class II | Terminated |
| D-1490-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 30 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-887-32; Blister NDC 68084-887-33 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 761 cartons | Class II | Terminated |
| D-1514-2016 | 08-24-2016 | Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540. | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised. | Sandoz Inc / a) 1,584 cartons; b) 62,170 vials | Class II | Terminated |
| D-1483-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 60687-133-25; Blister NDC 60687-133-95 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 1,416 cartons | Class II | Terminated |
| D-1513-2016 | 08-24-2016 | Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540. | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised. | Sandoz Inc / 32,099 cartons | Class II | Terminated |
| D-1482-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-936-25; Blister NDC 68084-936-95 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 2,276 cartons | Class II | Terminated |
| D-1485-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 60687-154-25; Blister NDC 60687-154-95 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 156 cartons | Class II | Terminated |
| D-0133-2017 | 08-24-2016 | Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054 | Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application. | Sandoz Inc / 42,740 cartons (24 count carton from 7 total lots) | Class II | Terminated |
| D-1481-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-874-25; Blister NDC 68084-874-95 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 221 cartons | Class II | Terminated |
| D-1488-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-832-25; Blister NDC 68084-832-95 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 666 cartons | Class II | Terminated |
| D-1484-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 20 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-943-25; Blister NDC 68084-943-95 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 867 cartons | Class II | Terminated |
| D-1489-2016 | 08-24-2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 25 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-909-32; Blister NDC 68084-909-33 | Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule | Amerisource Health Services / 115 cartons | Class II | Terminated |
| D-1479-2016 | 08-23-2016 | Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06 | Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples. | Stason Pharmaceuticals, Inc. / 17,013 units | Class III | Terminated |
| D-0429-2017 | 08-22-2016 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values. | Noven Pharmaceuticals, Inc. / 364,830 patches | Class II | Terminated |
| D-0428-2017 | 08-22-2016 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc, Miami, FL 33186, NDC 68968-5552-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values. | Noven Pharmaceuticals, Inc. / 1,068,600 patches | Class II | Terminated |
| D-0430-2017 | 08-22-2016 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values. | Noven Pharmaceuticals, Inc. / 357,420 patches | Class II | Terminated |
| D-1519-2016 | 08-19-2016 | Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05. Package NDCs: 29300-111-01; 29300-111-05; 29300-111-10; 29300-112-01; 29300-112-05; 29300-112-10; 29300-113-16; 29300-113-05; 29300-113-10; 29300-114-16; 29300-114-05; 29300-114-10 | Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets. | Unichem Pharmaceuticals Usa Inc / 368 bottles | Class III | Terminated |
| D-0215-2017 | 08-19-2016 | Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA | Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs | Impax Laboratories, Inc. / 3,074 boxes (30 count boxes) | Class I | Terminated |
| D-1515-2016 | 08-18-2016 | Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01, | Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed. | West-Ward Pharmaceuticals Corp. / 32,006 bottles (AS1413A) and 32,198 bottles (AS1414A) | Class III | Terminated |
| D-0216-2017 | 08-16-2016 | Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818 | Non Sterility; contaminated with Klebsiella pneumoniae | Sperian Eye & Face Protection, Inc / 9,744 bottles | Class I | Terminated |
| D-1500-2016 | 08-15-2016 | DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20 | Discoloration: Firm received complaints of product discoloration and particulates. | Hospira Inc. / 24000 vials | Class II | Terminated |
| D-1498-2016 | 08-10-2016 | Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605. | Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted. | Allergy Laboratories, Inc. / 1,928,075 vials | Class II | Terminated |
| D-1522-2016 | 08-08-2016 | Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-033-16. | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Pharmatech LLC / 1,332 bottles | Class II | Terminated |
| D-1520-2016 | 08-08-2016 | Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, NDC 76518-100-08. | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Pharmatech LLC / 1,008 bottles | Class II | Terminated |
| D-1521-2016 | 08-08-2016 | Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-032-16. Package NDCs: 23359-032-16; 23359-032-10; 23359-032-04 | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Pharmatech LLC / 5,928 bottles | Class II | Terminated |
| D-1524-2016 | 08-08-2016 | Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85. | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Pharmatech LLC / 19,656 bottles | Class II | Terminated |
| D-1526-2016 | 08-08-2016 | Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-6289-09. | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Pharmatech LLC / 68,908 bottles | Class II | Terminated |
| D-1525-2016 | 08-08-2016 | Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1000-59. | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Pharmatech LLC / 96,704 bottles | Class II | Terminated |
| D-1523-2016 | 08-08-2016 | Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1025-47. | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Pharmatech LLC / 12,308 bottles | Class II | Terminated |
| D-0005-2017 | 08-05-2016 | Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86 | Failed Impurities/Degradation Specifications. | Teva North America / 3,569 capsules | Class III | Terminated |
| D-1501-2016 | 08-04-2016 | buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03 | Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing. | Amerisource Health Services / 2626 bottles | Class III | Terminated |
| D-1518-2016 | 08-04-2016 | Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01 Package NDCs: 0024-5862-01 | Labeling: Incorrect or Missing Lot and/or Exp. Date | Genzyme Corporation / Genzyme Biosurgery / 9,530 vials | Class III | Terminated |
| D-0218-2017 | 08-04-2016 | Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02 Package NDCs: 0409-1159-18; 0409-1159-01; 0409-1159-19; 0409-1159-02; 0409-1160-18; 0409-1160-01; 0409-1162-18; 0409-1162-01; 0409-1162-19; 0409-1162-02; 0409-1163-18; 0409-1163-01; 0409-1165-18; 0409-1165-01; 0409-1165-19; 0409-1165-02; 0409-9043-11; 0409-9043-01; 0409-9046-11; 0409-9046-01; 0409-9045-11; 0409-9045-01; 0409-9045-16; 0409-9045-17; 0409-9042-11; 0409-9042-01; 0409-9042-16; 0409-9042-17 | Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial. | Hospira Inc., A Pfizer Company / 143,250 vials | Class I | Ongoing |
