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-0304-2021 | 01-27-2021 | Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01 | Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets. | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals / 12 bottles | Class II | Ongoing |
| D-0286-2021 | 01-27-2021 | Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose Vials per carton (NDC 71288-712-06), Rx only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL 60631. Package NDCs: 71288-712-05; 71288-712-06; 71288-714-10; 71288-714-11; 71288-713-20; 71288-713-21 | Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium | Meitheal Pharmaceuticals Inc / 34,860 vials | Class I | Terminated |
| D-0303-2021 | 01-27-2021 | Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA | Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets. | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals / 35 bottles | Class I | Ongoing |
| D-0249-2021 | 01-25-2021 | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. | Nostrum Laboratories Inc / 7071 bottles | Class II | Ongoing |
| D-0264-2021 | 01-22-2021 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68 Package NDCs: 67877-544-88; 67877-544-68; 67877-545-88; 67877-545-68 | CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. | Ascend Laboratories LLC / 23,436 200 mL bottles | Class II | Terminated |
| D-0263-2021 | 01-22-2021 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88 Package NDCs: 67877-544-88; 67877-544-68; 67877-545-88; 67877-545-68 | CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. | Ascend Laboratories LLC / 14,205 100 mL bottles | Class II | Terminated |
| D-0252-2021 | 01-21-2021 | Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar, Rx Only, Stanley Specialty Pharmacy 3120 Latrobe Dr. Suite 200 Charlotte, NC 28211 | Superpotent Drug. Lidocaine higher concentration than listed | Stanley Specialty Pharmacy Compounding and Wellness Center / 4400 grams (44 jars) | Class II | Terminated |
| D-0247-2021 | 01-21-2021 | Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01 Package NDCs: 68180-678-01 | Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point. | Lupin Pharmaceuticals Inc. / 46,479 bottles | Class III | Terminated |
| D-0290-2021 | 01-20-2021 | Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99 Package NDCs: 65862-859-30; 65862-859-01; 65862-859-05; 65862-859-99; 65862-859-10; 65862-859-78; 65862-860-30; 65862-860-01; 65862-860-05; 65862-860-99; 65862-860-10; 65862-860-78 | Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg. | Aurobindo Pharma USA Inc. / 1296 bottles | Class II | Terminated |
| D-1123-2022 | 01-15-2021 | Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 10702-0040-50 | Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules. | Calvin Scott & Company, Inc. / 13 bottles | Class III | Terminated |
| D-1124-2022 | 01-15-2021 | Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 67877-0573-05 | Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules. | Calvin Scott & Company, Inc. / 10 bottles | Class I | Terminated |
| D-0242-2021 | 01-11-2021 | Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun Pharma Ind. Inc, NJ 08512 Manufactured by: Sun Pharma Ind. Ltd., India NDC 62756-015-40 Package NDCs: 62756-017-40; 62756-015-40; 62756-016-40 | Incorrect Labeling: Incorrect lot number on secondary packaging | SUN PHARMACEUTICAL INDUSTRIES INC / 36,275 cartons | Class III | Terminated |
| D-0246-2021 | 01-08-2021 | Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1 Package NDCs: 51672-4001-6; 51672-4001-5; 51672-4001-1; 51672-4001-2; 51672-4002-6; 51672-4002-4; 51672-4002-5; 51672-4002-1; 51672-4002-2; 51672-4003-6; 51672-4003-5; 51672-4003-1; 51672-4003-2; 51672-4004-6; 51672-4004-5; 51672-4004-1; 51672-4004-2 | CGMP deviations. | Taro Pharmaceuticals U.S.A., Inc. / 44,256 bottles | Class II | Terminated |
| D-0232-2021 | 01-07-2021 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11 | Failed Dissolution Specifications | American Health Packaging / 1948 cartons | Class II | Terminated |
| D-0244-2021 | 01-07-2021 | Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30 | Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D. | Bausch Health Companies, Inc. / 14,089 bottles | Class III | Terminated |
| D-0243-2021 | 01-07-2021 | Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05 | Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D. | Bausch Health Companies, Inc. / 895 bottles | Class III | Terminated |
| D-0257-2021 | 01-06-2021 | Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ Fabricado por: De La Cruz Products, A Division of DLC Laboratories, Inc. Paramount, CA 9023 USA; UPC 024286150426 | Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product. | DLC Laboratories, Inc / 86,297 jars | Class II | Terminated |
| D-0227-2021 | 01-04-2021 | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Nostrum Laboratories Inc / 6958 Bottles | Class II | Ongoing |
| D-0228-2021 | 01-01-2021 | Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080. | cGMP deviations: The firm was notified of the manufacturer's expanded recall. | Precision Dose Inc. / 1,107,510 unit dose cups | Class II | Terminated |
| D-0233-2021 | 12-30-2020 | Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ 07940 UPC 3 00236 63410 0, NDC 0023-6634-10. Package NDCs: 0023-6634-10; 0023-6634-01; 0023-6634-20 | Labeling: Missing instructions for use insert | Allergan, PLC. / 100,634 bottles | Class II | Terminated |
| D-0248-2021 | 12-30-2020 | Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India NDC 55150-307-01 Package NDCs: 55150-307-01; 55150-307-24 | Discoloration and failed pH specifications | AuroMedics Pharma LLC / 3094 cartons | Class II | Terminated |
| D-0221-2021 | 12-28-2020 | Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16 | Defective container: Customer complaints for oral solution leaking from bottles. | Akorn, Inc. / 22,248 bottles | Class II | Terminated |
| D-0222-2021 | 12-28-2020 | Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL | cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions | Sunstar Americas, Inc. / a) 1,021,914 bottles; b) 255,552 bottles | Class II | Ongoing |
| D-0245-2021 | 12-23-2020 | Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Package NDCs: 63323-161-00; 63323-161-01; 63323-162-11; 63323-162-51; 63323-162-00; 63323-162-01; 63323-162-03; 63323-162-02 | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC / 945,425 vials | Class I | Terminated |
| D-0231-2021 | 12-23-2020 | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups) Package NDCs: 64950-353-03; 64950-353-01; 64950-353-91; 64950-353-51; 64950-353-02; 64950-353-92; 64950-353-52; 64950-354-10; 64950-354-50; 64950-354-05; 64950-354-55; 64950-354-45 | Presence of Foreign Substance: Particulate matter was found in multiple lots of product. | Genus Lifesciences Inc. / 1,171,550 cups | Class III | Terminated |
| D-0240-2021 | 12-23-2020 | IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as a) SAFE-GUARD Products International, b) Safe-WAY JEVCO Wash-Free Hand Sanitizer, c) TRACTION CAPITAL, d) United States Census 2020. UPC 8 19845 00598 5 | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol. | Shane Erickson Inc / 42,157 bottles | Class II | Terminated |
| D-0241-2021 | 12-23-2020 | IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as Thrifty White Pharmacy Wash-Free Hand Sanitizer. UPC 8 19845 00599 2 | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol. | Shane Erickson Inc / 29,376 bottles | Class II | Terminated |
| D-0239-2021 | 12-23-2020 | IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottles, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384, Made in China, ALSO distributed with Custom front labels as follows a) Sadie G. Mays Health & Rehabilitation Center, b) Pacers logo, c) northwood CHURCH, d) ROGERTHEROOFER.com and e) SoFi Stadium Wash-Free Hand Sanitizer. UPC 8 19845 00597 8 | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol. | Shane Erickson Inc / 36,505 bottles | Class II | Terminated |
| D-0180-2021 | 12-22-2020 | NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Package NDCs: 64380-720-06; 64380-720-01; 64380-721-06; 64380-721-01; 64380-722-01; 64380-722-06 | Failed Moisture Limits | Strides Pharma Inc. / 960 bottles | Class III | Terminated |
| D-0307-2021 | 12-22-2020 | Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01 | Labeling: Incorrect or Missing Lot and/or Exp Date | Edge Pharma, LLC / 60 syringes | Class III | Terminated |
| D-0176-2021 | 12-21-2020 | Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc., NDC 67919-030-01 Package NDCs: 67919-030-01 | Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches. | Merck Sharp & Dohme / 106,503 vials | Class II | Terminated |
| D-0224-2021 | 12-18-2020 | Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01 | Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A | KVK-Tech, Inc. / 528 bottles | Class III | Terminated |
| D-0179-2021 | 12-17-2020 | Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68 Package NDCs: 67877-544-88; 67877-544-68; 67877-545-88; 67877-545-68 | Failed Impurity/Degradation Specifications | Ascend Laboratories LLC / 9,524 bottles | Class II | Terminated |
| D-0181-2021 | 12-17-2020 | Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-527-34 Package NDCs: 69097-527-34 | Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline | CIPLA / 284,610 packets | Class II | Terminated |
| D-0269-2021 | 12-17-2020 | ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle, 270 measured sprays, Distributed by Ndal Laboratories, 449 Alvarado St., Monterey, CA 93940 (bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8. the Alvarado St. is for the bottle by putting "(bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8." (according to the label) | Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast | NDAL Mfg Inc. / 4265 bottles | Class I | Ongoing |
| D-0182-2021 | 12-17-2020 | Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-528-34 Package NDCs: 69097-528-34; 69097-529-34 | Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline | CIPLA / 289350 packets | Class II | Terminated |
| D-0184-2021 | 12-17-2020 | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02 Package NDCs: 63323-161-00; 63323-161-01; 63323-162-11; 63323-162-51; 63323-162-00; 63323-162-01; 63323-162-03; 63323-162-02 | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC / 490,633 vials | Class II | Terminated |
| D-0177-2021 | 12-17-2020 | Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979 | Lack of assurance of sterility: 13 vials were discovered to have faulty crimps. | Imprimis NJOF, LLC / 6520 vials | Class II | Terminated |
| D-0178-2021 | 12-17-2020 | Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88 Package NDCs: 67877-544-88; 67877-544-68; 67877-545-88; 67877-545-68 | Failed Impurity/Degradation Specifications | Ascend Laboratories LLC / 29,317 bottles | Class II | Terminated |
| D-0212-2021 | 12-17-2020 | SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 5067 syringes | Class II | Terminated |
| D-0190-2021 | 12-17-2020 | Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 952 syringes | Class II | Terminated |
| D-0200-2021 | 12-17-2020 | Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 7,275 syringes | Class II | Terminated |
| D-0195-2021 | 12-17-2020 | HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 3,092 syringes | Class II | Terminated |
| D-0183-2021 | 12-17-2020 | Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 NDC 69097-529-34 Package NDCs: 69097-528-34; 69097-529-34 | Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline | CIPLA / 6,491 packets | Class II | Terminated |
| D-0192-2021 | 12-17-2020 | fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 996 syringes | Class II | Terminated |
| D-0206-2021 | 12-17-2020 | Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode 70004085012 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 7,940 syringes | Class II | Terminated |
| D-0211-2021 | 12-17-2020 | Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 13,096 syringes | Class II | Terminated |
| D-0204-2021 | 12-17-2020 | PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 23,029 syringes | Class II | Terminated |
| D-0207-2021 | 12-17-2020 | Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 5,990 syringes | Class II | Terminated |
| D-0202-2021 | 12-17-2020 | morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 50 syringes | Class II | Terminated |
| D-0189-2021 | 12-17-2020 | ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 7,257 syringes | Class II | Terminated |
| D-0201-2021 | 12-17-2020 | Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 751 syringes | Class III | Terminated |
| D-0210-2021 | 12-17-2020 | PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 14,580 syringes | Class II | Terminated |
| D-0187-2021 | 12-17-2020 | Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe, Rx Only SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072509 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 3,793 syringes | Class II | Terminated |
| D-0216-2021 | 12-17-2020 | PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 3152 syringes | Class II | Terminated |
| D-0191-2021 | 12-17-2020 | fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 1,774 syringes | Class II | Terminated |
| D-0214-2021 | 12-17-2020 | fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 6710 syringes | Class II | Terminated |
| D-0203-2021 | 12-17-2020 | neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 390 syringes | Class II | Terminated |
| D-0198-2021 | 12-17-2020 | labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 9,057 syringes | Class II | Terminated |
| D-0215-2021 | 12-17-2020 | HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 428 syringes | Class II | Terminated |
| D-0194-2021 | 12-17-2020 | Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 1,614 syringes | Class II | Terminated |
| D-0205-2021 | 12-17-2020 | PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081612 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 7,890 syringes | Class II | Terminated |
| D-0213-2021 | 12-17-2020 | ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 9416 syringes | Class II | Terminated |
| D-0208-2021 | 12-17-2020 | SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090812 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 3,239 syringes | Class II | Terminated |
| D-0209-2021 | 12-17-2020 | Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 116 syringes | Class II | Terminated |
| D-0197-2021 | 12-17-2020 | Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 11,075 syringes | Class II | Terminated |
| D-0196-2021 | 12-17-2020 | HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 1,056 syringes | Class II | Terminated |
| D-0188-2021 | 12-17-2020 | ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 1,879 syringes | Class II | Terminated |
| D-0199-2021 | 12-17-2020 | Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 1,880 syringes | Class II | Terminated |
| D-0217-2021 | 12-17-2020 | Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 9942 syringes | Class II | Terminated |
| D-0186-2021 | 12-17-2020 | Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 1,930 syringes | Class II | Terminated |
| D-0193-2021 | 12-17-2020 | fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 2,834 syringes | Class II | Terminated |
| D-0223-2021 | 12-16-2020 | Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032 | Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible. | US Compounding Inc / 1534 syringes | Class III | Terminated |
| D-0171-2021 | 12-14-2020 | Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232 | Subpotent drug. | SCA Pharmaceuticals, Inc. / 654 bags | Class II | Terminated |
| D-0165-2021 | 12-14-2020 | Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40 | cGMP deviations: Vials may not be sealed correctly affecting sterility. | CIPLA / 2151 vials | Class II | Terminated |
| D-0172-2021 | 12-10-2020 | Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Package NDCs: 63323-465-01; 63323-465-57; 63323-467-01; 63323-467-57; 63323-460-01; 63323-460-37; 63323-464-02; 63323-464-37; 63323-464-03; 63323-464-31; 63323-466-01; 63323-466-37; 63323-466-02; 63323-466-31; 63323-462-04; 63323-462-17; 63323-462-01; 63323-462-37; 63323-462-02; 63323-462-31 | Subpotent Drug: Low out-of-specification assay results for the epinephrine component. | Fresenius Kabi USA, LLC / 4411 trays | Class II | Terminated |
| D-0148-2021 | 12-09-2020 | Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured for: Biogen Inc., Cambridge, MA 02142, NDC 64406-020-01 Package NDCs: 64406-020-01; 64406-020-03; 64406-020-05; 64406-020-07 | Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing. | Biogen MA Inc. / 5,307 bottles | Class II | Terminated |
| D-0170-2021 | 12-09-2020 | Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 59922-631-01 Package NDCs: 59922-631-01 | CGMP Deviations | Akebia Therapeutics dba Keryx Biopharmaceutials, Inc / 2,170 bottles | Class II | Terminated |
| D-0174-2021 | 12-09-2020 | Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053 | Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities. | Morton Grove Pharmaceuticals, Inc. / 127,392 bottles | Class II | Terminated |
| D-0124-2021 | 12-08-2020 | Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90. Package NDCs: 72485-202-90 | CGMP Deviations | Shilpa Medicare Limited / 2611 bottles | Class II | Terminated |
| D-0125-2021 | 12-08-2020 | Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30. Package NDCs: 72485-203-30 | CGMP Deviations | Shilpa Medicare Limited / 4166 bottles | Class II | Terminated |
| D-0122-2021 | 12-08-2020 | Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01. Package NDCs: 72485-201-01 | CGMP Deviations | Shilpa Medicare Limited / 35,931 vials | Class II | Terminated |
| D-0123-2021 | 12-08-2020 | Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01. | CGMP Deviations | Shilpa Medicare Limited / 6,560 vials | Class II | Terminated |
| D-0121-2021 | 12-08-2020 | Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, Vial NDC 72485-210-01, Carton NDC 72485-210-08. | CGMP Deviations | Shilpa Medicare Limited / 2,064 vials | Class II | Terminated |
| D-0126-2021 | 12-08-2020 | Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72485-216-08. | CGMP Deviations | Shilpa Medicare Limited / 2008 vials | Class II | Terminated |
| D-0167-2021 | 12-07-2020 | Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01. | Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility. | AVKARE Inc. / 38715 bottles | Class II | Terminated |
| D-0168-2021 | 12-07-2020 | TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10 | Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility. | AVKARE Inc. / 14368 bottles | Class I | Terminated |
| D-0169-2021 | 12-07-2020 | Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17 Package NDCs: 0641-0497-17; 0641-0497-25; 0641-6144-01; 0641-6144-25 | Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial. | Hikma Pharmaceuticals USA Inc. / 1,324,072 vials | Class II | Terminated |
| D-0145-2021 | 12-03-2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77 Package NDCs: 68382-771-30; 68382-771-77; 68382-772-30; 68382-772-77 | Failed Dissolution Specifications | Zydus Pharmaceuticals (USA) Inc / 15,144 cartons | Class II | Terminated |
| D-0146-2021 | 12-03-2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-772-77 Package NDCs: 68382-771-30; 68382-771-77; 68382-772-30; 68382-772-77 | Failed Dissolution Specifications | Zydus Pharmaceuticals (USA) Inc / 22,848 cartons | Class II | Terminated |
| D-0230-2021 | 12-01-2020 | Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala, Jalisco, Mexico, UPC: 7 501700 623504, NDC numbers: 76938-001-01, 76938-001-02, 76938-001-03. | cGMP deviations: Product made at the same facility where product tested was sub-potent. | GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION / 43875 liters | Class II | Ongoing |
| D-0229-2021 | 12-01-2020 | Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rural Rd.,Tempe AZ, 85283, Made in Mexico by: Gaza Proveedora De Servicios De Hospedaje y Alimentos S.A. de C.V., UPC 8 64972 00049 5, NDC 76540-100-02 | cGMP deviations: Product made at the same facility where product tested was sub-potent. | GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION / 26,000 liters | Class II | Ongoing |
| D-0130-2021 | 11-30-2020 | PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 1 vial | Class II | Ongoing |
| D-0133-2021 | 11-30-2020 | THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 4 vials | Class II | Ongoing |
| D-0139-2021 | 11-30-2020 | CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 1 vial | Class II | Ongoing |
| D-0134-2021 | 11-30-2020 | IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 3 vials | Class II | Ongoing |
| D-0128-2021 | 11-30-2020 | CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 6 vials | Class II | Ongoing |
| D-0141-2021 | 11-30-2020 | GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 1 vial | Class II | Ongoing |
| D-0140-2021 | 11-30-2020 | THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 3 vials | Class II | Ongoing |
| D-0132-2021 | 11-30-2020 | BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Advanced Nutriceuticals, LLC / 4 vials | Class II | Ongoing |
