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-0982-2017 | 05-24-2017 | PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981 | Failed Dissolution Specifications: Low dissolution results were obtained during stability testing | Shionogi Inc. / 455 bottles | Class III | Terminated |
| D-1096-2017 | 05-22-2017 | Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLine Nutrients Corp, 1801 S. Canal St, Chicago, IL 60616, UPC 021754905076 | Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use. | Global Marketing Enterprises, Inc. / 52.5 kg | Class II | Terminated |
| D-0885-2017 | 05-22-2017 | Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-113-81 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: out of specification results observed for low dissolution. | Dr. Reddy's Laboratories, Inc. / 223,650 cartons | Class II | Terminated |
| D-0883-2017 | 05-22-2017 | Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81 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: out of specification results observed for low dissolution. | Dr. Reddy's Laboratories, Inc. / 13,221 cartons | Class II | Terminated |
| D-0884-2017 | 05-22-2017 | Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, 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: out of specification results observed for low dissolution. | Dr. Reddy's Laboratories, Inc. / 89,118 cartons | Class II | Terminated |
| D-0886-2017 | 05-22-2017 | Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-137-81 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: out of specification results observed for low dissolution. | Dr. Reddy's Laboratories, Inc. / 452,290 cartons | Class II | Terminated |
| D-1087-2017 | 05-19-2017 | Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by: Dynamic Technical Formulations 12850 Hwy 9 Suite 600-441 Alpharetta, GA 30004 | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine. | DYNAMIC TECHNICAL FORMULATIONS / 728 bottles | Class I | Terminated |
| D-0942-2017 | 05-18-2017 | Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01 | Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent | Lantheus MI Radipharmaceuticals Inc. / 26 doses | Class III | Terminated |
| D-0874-2017 | 05-18-2017 | fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 100 bags | Class II | Terminated |
| D-0878-2017 | 05-18-2017 | MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 40 bags | Class II | Terminated |
| D-0877-2017 | 05-18-2017 | ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 70 bags | Class II | Terminated |
| D-0872-2017 | 05-18-2017 | fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 118 bags | Class II | Terminated |
| D-0879-2017 | 05-18-2017 | PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 30 bags | Class II | Terminated |
| D-0873-2017 | 05-18-2017 | fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 370 bags | Class II | Terminated |
| D-0875-2017 | 05-18-2017 | HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 87 bags | Class II | Terminated |
| D-0876-2017 | 05-18-2017 | ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0522-32 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 240 bags | Class II | Terminated |
| D-0870-2017 | 05-18-2017 | morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32. | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 80 bags | Class II | Terminated |
| D-0871-2017 | 05-18-2017 | morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-55 | Lack of assurance of sterility: Product bags leaking at seam. | SCA Pharmaceuticals / 56 bags | Class II | Terminated |
| D-0898-2017 | 05-18-2017 | Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04 Package NDCs: 0409-3375-14; 0409-3375-04; 0409-1443-14; 0409-1443-04 | GMP Deviation; A foreign stopper was observed during packaging of a lot of product. | Hospira Inc., A Pfizer Company / (720503A): 43,200 vials, (720603A): 400 vials | Class II | Terminated |
| D-0880-2017 | 05-18-2017 | Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmaceuticals, Inc. subsidiary of Forest Laboratories, LLC, Cincinnati OH 45209 USA --- NDC 0456-2410-60; Shellpack containing 1 blister card --- NDC 0456-2410-06 Package NDCs: 0456-2402-10; 0456-2402-06; 0456-2402-60; 0456-2402-11; 0456-2402-63; 0456-2405-10; 0456-2405-06; 0456-2405-60; 0456-2405-11; 0456-2405-63; 0456-2410-10; 0456-2410-06; 0456-2410-60; 0456-2410-11; 0456-2410-63 | Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets | Forest Laboratories, LLC / 40,621 blister packs | Class II | Terminated |
| D-0869-2017 | 05-17-2017 | Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771. | Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification. | VistaPharm, Inc. / 2,208,500 cups/18696 bottles | Class III | Terminated |
| D-1059-2017 | 05-17-2017 | Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61 | Presence of Foreign Substance: potential presence of plastic particles. | X-Gen Pharmaceuticals Inc. / 9,816 bottles | Class II | Terminated |
| D-1093-2017 | 05-16-2017 | Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 | Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package. | Lupin Limited (Unit 1) / 24,652 tablets | Class I | Terminated |
| D-0793-2017 | 05-16-2017 | Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20. Package NDCs: 0173-0682-20; 0173-0682-24 | Defective Delivery System: Elevated number of units with out of specification results for leak rate | GlaxoSmithKline, LLC / 562,883 | Class II | Ongoing |
| D-0789-2017 | 05-15-2017 | Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48 Package NDCs: 0338-6010-48; 0338-6011-37 | Lack of assurance of sterility: customer complaints received for the presence of leaks. | Baxter Healthcare Corporation / 90,450 bags | Class II | Terminated |
| D-0788-2017 | 05-15-2017 | Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48 Package NDCs: 0338-6046-48; 0338-6045-37 | Lack of assurance of sterility: customer complaints received for the presence of leaks. | Baxter Healthcare Corporation / 113,590 bags | Class II | Terminated |
| D-1060-2017 | 05-11-2017 | Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485. | GMP Deviations: The firm does not include an SOP for testing for out of specifications. | AtHome Medical, Inc. / 80 lbs | Class II | Terminated |
| D-1041-2017 | 05-10-2017 | Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01 | Failed Dissolution Specifications | Zydus Pharmaceuticals USA Inc / 108,096 HDPE bottles | Class II | Terminated |
| D-1042-2017 | 05-10-2017 | Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054 | Failed Dissolution Specifications | Zydus Pharmaceuticals USA Inc / 115,122 HDPE bottles | Class II | Terminated |
| D-1043-2017 | 05-10-2017 | Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054 | Failed Dissolution Specifications | Zydus Pharmaceuticals USA Inc / 108,726 HDPE bottles | Class II | Terminated |
| D-0858-2017 | 05-09-2017 | Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06 Package NDCs: 64380-712-06; 64380-712-07; 64380-713-06; 64380-713-07 | Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content. | Strides Pharma INC / 127,517 bottles | Class III | Terminated |
| D-0920-2017 | 05-09-2017 | Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93 | Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities | Mylan Pharmaceuticals Inc. / 11,624 pouches | Class III | Terminated |
| D-0859-2017 | 05-08-2017 | HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52. | Superpotent Drug: above specification for the assay. | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals / 109,620 bottles | Class III | Terminated |
| D-1092-2017 | 05-05-2017 | GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842 | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances. | Genetic Edge Compounds LLC / 1759 bottles ( 105, 540 capsules) | Class I | Terminated |
| D-1134-2017 | 05-05-2017 | AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10 Package NDCs: 67877-197-90; 67877-197-05; 67877-197-10; 67877-197-38; 67877-198-90; 67877-198-05; 67877-198-10; 67877-198-38; 67877-199-90; 67877-199-05; 67877-199-10; 67877-199-38 | PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg. | Ascend Laboratories LLC / 1212 bottles | Class III | Terminated |
| D-1127-2017 | 05-02-2017 | Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC 68180-150-01 Package NDCs: 68180-150-01 | CGMP Deviations | Lupin Pharmaceuticals Inc. / 12,888 bottles | Class III | Terminated |
| D-0929-2017 | 05-01-2017 | Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by Allergan, Irvine, California, 92612, U.S.A., NDC: 0023-0313-04. | Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities. | Allergan Sales, LLC / 648 units | Class II | Terminated |
| D-0698-2017 | 04-28-2017 | Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY 10977. Package NDCs: 42023-179-05; 42023-179-01 | Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component. | PAR Sterile Products LLC / 122,469 cartons | Class II | Terminated |
| D-0897-2017 | 04-27-2017 | Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-778-01 Package NDCs: 31722-777-01; 31722-777-05; 31722-778-01; 31722-778-05 | Presence of Foreign Substance: human hair melded into tablet. | Hetero USA Inc / 13,692 bottles | Class III | Terminated |
| D-0923-2017 | 04-27-2017 | Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8 Package NDCs: 68968-6625-8; 68968-6637-8; 68968-6650-8; 68968-6675-8; 68968-6610-8 | Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH. | Noven Pharmaceuticals, Inc. / 14434 cartons | Class III | Terminated |
| D-0868-2017 | 04-26-2017 | Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20 Package NDCs: 0781-1874-31; 0781-1831-20; 0781-1831-13; 0781-1831-01; 0781-1852-20; 0781-1852-13; 0781-1852-01; 0781-6102-46; 0781-6102-57; 0781-6102-52; 0781-6104-46; 0781-6104-57; 0781-6104-52 | Subpotent Drug; Clavulanic Acid | Sandoz Inc / 4,464 bottles | Class III | Terminated |
| D-0705-2017 | 04-24-2017 | Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel | Microbial Contamination of Non-Sterile Products | Teva Pharmaceuticals USA / N/A | Class II | Terminated |
| D-0862-2017 | 04-21-2017 | Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10 Package NDCs: 0409-1775-40; 0409-1775-10 | Presence of Particulate Matter: human hair found within an internal sample syringe. | Hospira Inc. / 71,550 syringes | Class I | Ongoing |
| D-0697-2017 | 04-20-2017 | IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02 | Product is being recalled due to low pH value. | Akorn, Inc. / 1,292 kits | Class III | Terminated |
| D-1111-2017 | 04-20-2017 | Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10 | Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets | C. O. Truxton / unknown | Class I | Terminated |
| D-1116-2017 | 04-20-2017 | Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10 | Labeling: Label Mixup; potentially mislabeled | C. O. Truxton / unknown | Class II | Terminated |
| D-1112-2017 | 04-20-2017 | Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6145-10 | Labeling: Label Mixup; potentially mislabeled | C. O. Truxton / unknown | Class I | Terminated |
| D-1114-2017 | 04-20-2017 | Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031 | Labeling: Label Mixup; potentially mislabeled | C. O. Truxton / unknown | Class II | Terminated |
| D-1113-2017 | 04-20-2017 | Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6151-10 | Labeling: Label Mixup; potentially mislabeled | C. O. Truxton / unknown | Class II | Terminated |
| D-1115-2017 | 04-20-2017 | Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10 | Labeling: Label Mixup; potentially mislabeled | C. O. Truxton / unknown | Class II | Terminated |
| D-0866-2017 | 04-19-2017 | Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40 | GMP Deviations; product may not meet cGMP requirements | Gentell, Inc / 65 gallons | Class II | Terminated |
| D-0891-2017 | 04-19-2017 | Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01 | CGMP deviations- Lack of Quality Assurance | Qualgen / 4,468 pellets. | Class II | Terminated |
| D-0893-2017 | 04-19-2017 | Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-015-01 | CGMP deviations- Lack of Quality Assurance | Qualgen / 6,227 pellets | Class II | Terminated |
| D-0892-2017 | 04-19-2017 | Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01. | CGMP deviations- Lack of Quality Assurance | Qualgen / 6,361 pellets. | Class II | Terminated |
| D-0890-2017 | 04-19-2017 | Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01 | CGMP deviations- Lack of Quality Assurance | Qualgen / 1,666 pellets. | Class II | Terminated |
| D-0894-2017 | 04-19-2017 | Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-012-01 | CGMP deviations- Lack of Quality Assurance | Qualgen / 4,883 pellets. | Class II | Terminated |
| D-0895-2017 | 04-19-2017 | Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-010-01 | CGMP deviations- Lack of Quality Assurance | Qualgen / 5,260 pellets. | Class II | Terminated |
| D-0889-2017 | 04-19-2017 | Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01, | CGMP deviations- Lack of Quality Assurance | Qualgen / 1,153 pellets. | Class II | Terminated |
| D-0896-2017 | 04-19-2017 | Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by; Qualgen 14844 Bristol Park Blvd. Edmond, OK 73013 NDC: 69761-006-01. | CGMP deviations- Lack of Quality Assurance | Qualgen / 4,815 pellets. | Class II | Terminated |
| D-0109-2018 | 04-18-2017 | Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles, Rx only, Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA, Distributed by: Sun Pharmaceutical Industries, Cranbury, NJ 08512 Package NDCs: 10631-238-01; 10631-238-02; 10631-206-01; 10631-206-02 | Microbial Contamination of Non-Sterile Products | Sun Pharmaceutical Industries, Inc. / N/A | Class II | Terminated |
| D-0857-2017 | 04-18-2017 | Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83. | Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness. | Sun Pharmaceutical Industries, Inc. / 13,200 bottles | Class III | Terminated |
| D-0771-2017 | 04-18-2017 | PROCAINE HCL 50ML MDV (CALIF) 1% INJ, Injection, 1%, Rx only, 50mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0720-2017 | 04-18-2017 | HCG *10ML* MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 72 vials | Class II | Terminated |
| D-0717-2017 | 04-18-2017 | FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 20 vials | Class II | Terminated |
| D-0782-2017 | 04-18-2017 | TESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0780-2017 | 04-18-2017 | SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 75 mL | Class II | Terminated |
| D-0768-2017 | 04-18-2017 | MAGNESIUM SO4 10ML MDV 50% INJ, Injection, 50%, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 3 vials | Class II | Terminated |
| D-0964-2017 | 04-18-2017 | Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA ---- UPC Code 680474015795 | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin | Organic Herbal Supply / | Class I | Terminated |
| D-0760-2017 | 04-18-2017 | CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/0.1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 1 vial | Class II | Terminated |
| D-0725-2017 | 04-18-2017 | HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple Dose and 30 mL Glass/ Multiple Dose vials,Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 7 vials total (1/5mL vial and 6/30 mL vials) | Class II | Terminated |
| D-0713-2017 | 04-18-2017 | CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ, Injection, 25mg/mL, Rx only, 20mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 1 vial | Class II | Terminated |
| D-0769-2017 | 04-18-2017 | METHYL-B12 5ML MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 26 vials | Class II | Terminated |
| D-0759-2017 | 04-18-2017 | VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multiple Dose bottle, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 10 mL | Class II | Terminated |
| D-0738-2017 | 04-18-2017 | TRI MIX 10/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/30mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 6 vials | Class II | Terminated |
| D-0754-2017 | 04-18-2017 | QUAD MIX 1/30/0.5/0.1 5ML MDV MCG/MG/MG/MG/ML INJ, Injection, 1mcg/30mg/0.5mg/0.15mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0786-2017 | 04-18-2017 | VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only, packaged in 2mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 5/2 mL vials | Class II | Terminated |
| D-0779-2017 | 04-18-2017 | SODIUM CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, 0.50%, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 30 mL | Class II | Terminated |
| D-0731-2017 | 04-18-2017 | PGE1 MDV 20MCG/ML INJ, Injection, 20mcg/mL, Rx only, packaged in a 5 mL, 10mL, and 15 mL Glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 5 vials total (2/5 mL vials, 1/10mL vial, and 2/15mL vials) | Class II | Terminated |
| D-0778-2017 | 04-18-2017 | SODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5mL Glass/Multiple Dose via, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0732-2017 | 04-18-2017 | PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0963-2017 | 04-18-2017 | ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 852675999451 | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin | Organic Herbal Supply / | Class I | Terminated |
| D-0776-2017 | 04-18-2017 | PYRIDOXAL-5-PHOS 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 1 vial | Class II | Terminated |
| D-0965-2017 | 04-18-2017 | RECTALIS Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY --- UPC Code 680474228782 | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin | Organic Herbal Supply / | Class I | Terminated |
| D-0970-2017 | 04-18-2017 | ZRECT for Women Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packages, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 680474229055 | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin | Organic Herbal Supply / | Class I | Terminated |
| D-0967-2017 | 04-18-2017 | ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 680474229062 | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin | Organic Herbal Supply / | Class I | Terminated |
| D-0969-2017 | 04-18-2017 | ENHANCEROL Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086 | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin | Organic Herbal Supply / | Class I | Terminated |
| D-0722-2017 | 04-18-2017 | HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 2ML SDV 10MG/ML INJ, Injection, 10mg/mL, RX only, 2 mL glass/ Single Dose vial. | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 50 vials total (10/1mL vials and 40/2mL vials) | Class II | Terminated |
| D-0749-2017 | 04-18-2017 | TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ, Injection, 45.45mcg/27.27mg/0.45mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 1 vial | Class II | Terminated |
| D-0764-2017 | 04-18-2017 | IRON SPECIAL 5ML MDV 60/10MG/5MCG/ML INJ, Injection, 60mg/1mg/5mcg/mL, Rx only, 5mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0723-2017 | 04-18-2017 | HYDROXO-B12 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 240 mL | Class II | Terminated |
| D-0742-2017 | 04-18-2017 | TRI MIX 20/20/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/20mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 25 vials | Class II | Terminated |
| D-0750-2017 | 04-18-2017 | TRI MIX 5.88/17.65/0.588 5ML MDV MCG/MG/MG/ML INJ, , Injection, 5.88mcg/17.65mg/0.588mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 3 vials | Class II | Terminated |
| D-0707-2017 | 04-18-2017 | 5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 100 vials | Class II | Terminated |
| D-0708-2017 | 04-18-2017 | 5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 6 vials | Class II | Terminated |
| D-0785-2017 | 04-18-2017 | VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only, packaged in 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 6/1mL vials | Class II | Terminated |
| D-0743-2017 | 04-18-2017 | TRI MIX 20/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0756-2017 | 04-18-2017 | PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 3 vials | Class II | Terminated |
| D-0728-2017 | 04-18-2017 | HYDROXO-B12 5ML PBF MDV (CALIF) 10MG/ML INJ, Injection, 10mg/mL, RX only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 1 vial | Class II | Terminated |
| D-0773-2017 | 04-18-2017 | PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 86 vials total (78/5mL vials and 8/50mL vials) | Class II | Terminated |
| D-0747-2017 | 04-18-2017 | TRI MIX 40/30/2 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
