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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0679-2018 | 03-22-2018 | Estradiol 40 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0674-2018 | 03-22-2018 | Estradiol 12.5 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0670-2018 | 03-22-2018 | Testosterone/Anastrozole 200 mg/20 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0659-2018 | 03-22-2018 | TM #6 (ALP 25/PAPAV/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0640-2018 | 03-22-2018 | Lipoic Acid 25mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0636-2018 | 03-22-2018 | Biotin Suspension 10mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 2 vials | Class II | Terminated |
| D-0649-2018 | 03-22-2018 | Pregnenolone 100 mg (SD) pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / one vial | Class II | Terminated |
| D-0665-2018 | 03-22-2018 | Testosterone 37.5 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0651-2018 | 03-22-2018 | Testosterone/Anastrozole 120 mg/8 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0639-2018 | 03-22-2018 | HCG 1000 units/mL, packaged in a) 2 mL and b) 6 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / four vials | Class II | Terminated |
| D-0662-2018 | 03-22-2018 | Testosterone 200 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0673-2018 | 03-22-2018 | Estradiol 10 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0678-2018 | 03-22-2018 | Estradiol 35 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0661-2018 | 03-22-2018 | TM #3 (ALP10/PAPAV12/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0658-2018 | 03-22-2018 | TM #4 (ALP 20/PAPAV/PHENT 2), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0642-2018 | 03-22-2018 | Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL amber vial and b) 50mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0650-2018 | 03-22-2018 | Progesterone 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 twist top surrounded by a wrapper, | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / five vials | Class II | Terminated |
| D-0671-2018 | 03-22-2018 | Testosterone/Anastrozole 60 mg/1 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0644-2018 | 03-22-2018 | Testosterone Cypionate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 7 vials | Class II | Terminated |
| D-0664-2018 | 03-22-2018 | Testosterone 25 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0663-2018 | 03-22-2018 | Testosterone 100 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0641-2018 | 03-22-2018 | Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 11 vials | Class II | Terminated |
| D-0656-2018 | 03-22-2018 | MVI-7 (B1-100mg/B3-100mg, B5-252 mg, B6-102mg, Vit C-2500 mg, B12-10mg, Mag-1000 mg)/ vial liquid injectable, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0675-2018 | 03-22-2018 | Estradiol 15 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0682-2018 | 03-22-2018 | Testosterone/Finasteride 80 mg/8 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0660-2018 | 03-22-2018 | TM (ALP 50/PAPAV 30/PHENT1.5 mg), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0669-2018 | 03-22-2018 | Testosterone 80 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0638-2018 | 03-22-2018 | Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / four vials | Class II | Terminated |
| D-0653-2018 | 03-22-2018 | Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 7 vials | Class II | Terminated |
| D-0666-2018 | 03-22-2018 | Testosterone 40 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0648-2018 | 03-22-2018 | Naltrexone 200 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0645-2018 | 03-22-2018 | TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 15 vials | Class II | Terminated |
| D-0616-2018 | 03-21-2018 | Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10. Package NDCs: 51862-295-50; 51862-295-10 | Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point. | Mayne Pharma Inc / 3312 cans | Class III | Terminated |
| D-0606-2018 | 03-19-2018 | Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01. Package NDCs: 68462-406-01; 68462-406-10; 68462-302-01; 68462-302-05 | Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day. | Glenmark Pharmaceuticals Inc., USA / 109,080 Bottles | Class III | Terminated |
| D-0620-2018 | 03-19-2018 | Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wales, PA 19454. Package NDCs: 0093-3223-08; 0093-3223-19; 0093-3223-97 | Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator. | Teva Pharmaceuticals USA / 640,486 vaginal inserts | Class II | Terminated |
| D-0626-2018 | 03-19-2018 | Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care Products, Temperance, MI 48182 Mfr. CSPC Ouyl Pharm Co., Ltd. Shijazhuang, Hebei, China; NDC 55700-0412-01 | Labeling: Incorrect or Missing Lot and/or Exp Date | Lake Erie Medical & Surgical Supply Inc / 16 paper cartons | Class III | Terminated |
| D-0618-2018 | 03-15-2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03 Package NDCs: 69097-877-02; 69097-877-03; 69097-877-07; 69097-877-12; 69097-878-02; 69097-878-03; 69097-878-07; 69097-878-12; 69097-879-02; 69097-879-03; 69097-879-07; 69097-879-12 | Failed Dissolution Specifications; during stability testing | InvaGen Pharmaceuticals, Inc. / N/A | Class III | Terminated |
| D-0619-2018 | 03-15-2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Package NDCs: 69097-877-02; 69097-877-03; 69097-877-07; 69097-877-12; 69097-878-02; 69097-878-03; 69097-878-07; 69097-878-12; 69097-879-02; 69097-879-03; 69097-879-07; 69097-879-12 | Failed Dissolution Specifications; during stability testing | InvaGen Pharmaceuticals, Inc. / N/A | Class III | Terminated |
| D-0697-2018 | 03-15-2018 | All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall. | Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton. | Bayer HealthCare Pharmaceuticals, Inc. / 188,631 units | Class I | Terminated |
| D-0617-2018 | 03-09-2018 | Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60. | Failed Impurities/Degradation Specifications: High out of specification results for an impurity. | Akorn, Inc. / 4,128 bottles | Class III | Terminated |
| D-0589-2018 | 03-09-2018 | Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharmacal Cos., Inc., Niles, IL 60714, USA. NDC 52389-745-56, UPC 0 72959 01045 4. | Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period. | Alva-Amco Pharmacal Companies., Inc. / 206,513 tubes | Class III | Terminated |
| D-0625-2018 | 03-08-2018 | Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021 | Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction. | Jimmy Weber / 315 capsules | Class I | Terminated |
| D-0598-2018 | 03-08-2018 | Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90 | Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing. | Dr. Reddy's Laboratories, Inc. / 4,152 tubes | Class III | Terminated |
| D-0609-2018 | 03-08-2018 | E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01 Package NDCs: 32909-770-01 | Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot. | Bracco Diagnostics Inc. / 2,136 tubes | Class II | Terminated |
| D-0591-2018 | 03-07-2018 | Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3 | Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed. | American Pharmaceutical Ingredients LLC / 21 g | Class II | Terminated |
| D-0614-2018 | 03-07-2018 | Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25. | Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. | Apollo Care / 144 bags | Class II | Terminated |
| D-0592-2018 | 03-07-2018 | Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients | Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed. | American Pharmaceutical Ingredients LLC / 1460 GM | Class II | Terminated |
| D-0615-2018 | 03-07-2018 | Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25. | Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. | Apollo Care / 96 bags | Class II | Terminated |
| D-0586-2018 | 03-05-2018 | methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05. | Failed Impurities/Degradation Specifications: High out of specification results for an impurity. | Sagent Pharmaceuticals Inc / 205,370 vials | Class II | Terminated |
| D-0587-2018 | 03-05-2018 | methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10. | Failed Impurities/Degradation Specifications: High out of specification results for an impurity. | Sagent Pharmaceuticals Inc / 176,410 vials | Class II | Terminated |
| D-0588-2018 | 03-05-2018 | methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30. | Failed Impurities/Degradation Specifications: High out of specification results for an impurity. | Sagent Pharmaceuticals Inc / 48,964 vials | Class II | Terminated |
| D-0607-2018 | 03-05-2018 | Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01 | Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product. | Pine Pharmaceuticals, LLC / 136 units | Class III | Terminated |
| D-0698-2018 | 03-05-2018 | Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37 | Failed impurities/degradation specifications: Failure to water content and impurity | InvaGen Pharmaceuticals, Inc. / 3222 vials | Class III | Terminated |
| D-0599-2018 | 03-05-2018 | Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038 Package NDCs: 43386-118-03; 43386-118-01; 43386-118-05; 3433861180 | Failed Impurities/Degradation Specifications | Novel Laboratories, Inc. / 134,364 bottles (4,030,920 tablets) | Class III | Terminated |
| D-1077-2019 | 03-05-2018 | Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742 | Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API. | Johnson Matthey Inc. / 169.976 kg | Class II | Terminated |
| D-0605-2018 | 03-02-2018 | Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10 | Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability | Renaissance Lakewood, LLC / 1277 bags | Class III | Terminated |
| D-0581-2018 | 02-28-2018 | Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10 Package NDCs: 13811-709-10; 13811-706-10; 13811-707-10; 13811-708-10; 13811-710-10; 13811-710-30 | Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet. | Osmotica Pharmaceutical Corp / 19,664 100-bottles | Class III | Terminated |
| D-0608-2018 | 02-26-2018 | Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27 Package NDCs: 0574-2067-27; 0574-2067-00 | Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product. | Paddock Laboratories, LLC. / 52,596 bottles | Class II | Terminated |
| D-0914-2018 | 02-26-2018 | RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10 | Failed Stability Specifications | Mckesson Packaging Services / 17,192 cartons (1,719,200 tablets) | Class II | Terminated |
| D-0590-2018 | 02-23-2018 | Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636. | Labeling: Label mix-up | Bayer HealthCare Pharmaceuticals, Inc. / 528 units | Class II | Terminated |
| D-0585-2018 | 02-23-2018 | Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmington, DE 19850 by: Patheon Pharmaceuticals, Inc. Cincinnati OH 45237 Product of Switzerland NDC 0310-0657-58 | Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph). | AstraZeneca Pharmaceuticals LP / 18056 bottles | Class III | Terminated |
| D-0603-2018 | 02-22-2018 | labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028 | Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018 | SCA Pharmaceuticals, LLC. / 480 syringes | Class III | Terminated |
| D-0696-2018 | 02-21-2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, India 382213, NDC 36000-002-10 | Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags. | Renaissance Lakewood, LLC / 1784 bags | Class II | Terminated |
| D-0577-2018 | 02-21-2018 | Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05 | Failed Stability Specification: OOS low viscosity results discovered during retain testing. | Akorn, Inc. / 31,812 bottles | Class III | Terminated |
| D-0576-2018 | 02-20-2018 | Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25. Package NDCs: 0409-2267-20; 0409-2267-54; 0409-0125-01; 0409-0125-25; 0409-2267-25 | Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal. | Hospira Inc. A Pfizer Company / a) 137,975 vials; b) 40,143 vials | Class II | Terminated |
| D-0582-2018 | 02-19-2018 | Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05 | cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | Kalchem International, Inc. / 500 gram jar | Class II | Terminated |
| D-0549-2018 | 02-16-2018 | 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00. Package NDCs: 0264-2201-00; 0264-2201-10; 0264-2201-50; 0264-2201-70 | Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received. | B. Braun Medical Inc / 17,360 plastic irrigation containers | Class II | Terminated |
| D-0546-2018 | 02-15-2018 | PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries, Inc., Northfield, IL 60093; Product Number MDS093945; NDC 53329-938-04 Package NDCs: 53329-938-06; 53329-938-08; 53329-938-23; 53329-938-25; 53329-938-04 | Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry. | Medline Industries Inc / 67,104 bottles | Class II | Terminated |
| D-0579-2018 | 02-15-2018 | Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25. | Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. | Apollo Care / 360 bags | Class II | Terminated |
| D-0580-2018 | 02-15-2018 | Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-264-25. | Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. | Apollo Care / 312 bags | Class II | Terminated |
| D-0593-2018 | 02-14-2018 | Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015 | Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall. | Bella All Natural / 32 bottles | Class I | Terminated |
| D-0547-2018 | 02-14-2018 | SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120 | Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus). | Fagron, Inc / a) 1007 bottles (500 mL) and b) 738 bottles (4 L) | Class II | Terminated |
| D-0550-2018 | 02-14-2018 | Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01 Package NDCs: 54482-020-01; 54482-020-02; 54482-035-02 | Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride. | LEADIANT BIOSCIENCES, INC / 1,705 bottles | Class III | Terminated |
| D-0601-2018 | 02-13-2018 | Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60 Package NDCs: 31722-832-60; 31722-832-31; 31722-832-32 | Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018). | Hetero Labs Limited Unit V / 1764 60-count bottles | Class II | Terminated |
| D-0602-2018 | 02-13-2018 | Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India NDC # 31722-705-30 Package NDCs: 31722-704-30; 31722-704-60; 31722-704-90; 31722-704-01; 31722-704-05; 31722-704-31; 31722-704-32; 31722-705-30; 31722-705-60; 31722-705-90; 31722-705-01; 31722-705-05 | Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018). | Hetero Labs Limited Unit V / 48132 60-count bottles | Class II | Terminated |
| D-0473-2018 | 02-13-2018 | Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02 | Presence of Foreign Tablets/Capsules | Nostrum Laboratories Inc / 1,439,000 oral capsules | Class III | Terminated |
| D-0544-2018 | 02-09-2018 | Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478 Package NDCs: 50268-061-11; 50268-061-15; 50268-062-11; 50268-062-15 | Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities. | Apace KY LLC / 630 cartons | Class II | Terminated |
| D-0535-2018 | 02-09-2018 | Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-8120-8); d) 5000g (NDC 58597-8120-9); e) 25000g (NDC 58597-8120-3), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 200000 g | Class II | Terminated |
| D-0503-2018 | 02-09-2018 | Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58597-8355-6); b) 100g (NDC 58597-8355-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 5800 g | Class II | Terminated |
| D-0515-2018 | 02-09-2018 | Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4); b) 100g (NDC 58597-8429-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 29550 g | Class II | Terminated |
| D-0526-2018 | 02-09-2018 | Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 500g (NDC 58597-0078-7); c) 1000g (NDC 58597-0078-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 611400 g | Class II | Terminated |
| D-0524-2018 | 02-09-2018 | Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-4); c)100g (NDC 58597-8538-6); d) 500g (NDC 58597-8538-7); d) 1000g (NDC 58597-8538-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 90000 g | Class II | Terminated |
| D-0529-2018 | 02-09-2018 | Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4); b) 100g (NDC 58597-8032-6); c) 500g (NDC 58597-8032-7); d)1000g (NDC 58597-8032-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 63975 g | Class II | Terminated |
| D-0516-2018 | 02-09-2018 | Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4); c) 500g (NDC 58597-8077-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 6000 g | Class II | Terminated |
| D-0520-2018 | 02-09-2018 | Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (NDC 58597-8525-7); d)1000g (NDC 58597-8525-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 12300 g | Class II | Terminated |
| D-0522-2018 | 02-09-2018 | Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC 58597-8089-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 10000 g | Class II | Terminated |
| D-0484-2018 | 02-09-2018 | Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6); c) 500 g (NDC 58597-8012-7); d) 1000g (NDC 58597-8012-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 116850 g | Class II | Terminated |
| D-0479-2018 | 02-09-2018 | Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8198-3); b) 100g (NDC 58597-8198-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 1300 g | Class II | Terminated |
| D-0504-2018 | 02-09-2018 | Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 10000 g | Class II | Terminated |
| D-0539-2018 | 02-09-2018 | Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 58597-8276-4), d) 100g (NDC 58597-8276-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / N/A | Class II | Terminated |
| D-0475-2018 | 02-09-2018 | Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327. | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 684 g | Class II | Terminated |
| D-0506-2018 | 02-09-2018 | Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 166000 g | Class II | Terminated |
| D-0537-2018 | 02-09-2018 | Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8056-2); c) 5g (NDC 58597-8056-3); d) 10g (NDC 58597-8056-4), e) 25 g (NDC 58597-8056-4); f) 100g (NDC 58597-8056-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 10769 g | Class II | Terminated |
| D-0517-2018 | 02-09-2018 | Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); b) 500g (NDC 58597-8028-7); c) 1000g (NDC 58597-8028-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 20700 g | Class II | Terminated |
| D-0499-2018 | 02-09-2018 | Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4); b) 100g (NDC 58597-8053-6); c) 500g (NDC 58597-8053-7) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 4600 g | Class II | Terminated |
| D-0487-2018 | 02-09-2018 | Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8632-6); b)1000 g (NDC 58597-8632-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 10000 g | Class II | Terminated |
| D-0534-2018 | 02-09-2018 | Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6); b) 500g (NDC 58597-8039-7); c) 1000g (NDC 58597-8039-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 50000 g | Class II | Terminated |
| D-0508-2018 | 02-09-2018 | Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); b) 500g (NDC 58597-8359-7); c) 1000g (NDC 58597-8359-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 22900 g | Class II | Terminated |
| D-0510-2018 | 02-09-2018 | Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Water ford, MI 48327, NDC 58597-8055-8 | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 12000 g | Class II | Terminated |
| D-0521-2018 | 02-09-2018 | Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4. | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC / 10000 g | Class II | Terminated |
