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-1604-2019 | 07-12-2019 | Lipidtrol Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1621-2019 | 07-12-2019 | Yeast Douche Powder, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1588-2019 | 07-12-2019 | Asthma Balm 60 gram, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1615-2019 | 07-12-2019 | Sperm Booster, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1619-2019 | 07-12-2019 | Vertigo Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1613-2019 | 07-12-2019 | Prostatin Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1589-2019 | 07-12-2019 | Awake, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1605-2019 | 07-12-2019 | Lube Lax Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1618-2019 | 07-12-2019 | Thyro-H, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1611-2019 | 07-12-2019 | Pain Away, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1624-2019 | 07-12-2019 | Thyro-Lo, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1603-2019 | 07-12-2019 | Herpes-V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1591-2019 | 07-12-2019 | Bone Fixer, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1620-2019 | 07-12-2019 | Worm Off, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1592-2019 | 07-12-2019 | Cardia Forte, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1596-2019 | 07-12-2019 | Edema Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1601-2019 | 07-12-2019 | Herpes-P, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1612-2019 | 07-12-2019 | Pain Stopper, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1614-2019 | 07-12-2019 | Psoriasis Balm, 60 gram, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1595-2019 | 07-12-2019 | Dragon Pain Oil, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1580-2019 | 07-12-2019 | Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufactured for H.J. Harkins Company, Inc. dba Pharma Pac by Perrigo Co, Allegan, MI 49010, NDC 52959-0407-01 | CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility. | H J Harkins Company Inc dba Pharma Pac / 97 boxes | Class II | Terminated |
| D-1606-2019 | 07-12-2019 | Lump Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1608-2019 | 07-12-2019 | Lung Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1594-2019 | 07-12-2019 | Dragon Pain Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1597-2019 | 07-12-2019 | Fungo Balm, 30 gram, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1593-2019 | 07-12-2019 | Deafness Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1610-2019 | 07-12-2019 | Migraine Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1629-2019 | 07-12-2019 | Fungo Off Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1602-2019 | 07-12-2019 | Herpes-S, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies / N/A | Class II | Terminated |
| D-1737-2019 | 07-11-2019 | CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ. (89 mL) Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01529 6 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 167 cases | Class II | Terminated |
| D-1738-2019 | 07-11-2019 | Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsburg, PA 15239, USA. UPC 7 51393 00608 6 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 246 cases | Class II | Terminated |
| D-1726-2019 | 07-11-2019 | CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 48136 3 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 5017 cases | Class II | Terminated |
| D-1725-2019 | 07-11-2019 | Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion, 3.5 oz (99.2 g) Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL,60015. NDC 0363-0670-04, UPC 3 11917 19308 3 Package NDCs: 0363-0670-04 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 533 cases | Class II | Terminated |
| D-1730-2019 | 07-11-2019 | Adult Glycerin Suppositories, Package Size 100-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0441-00 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 880 cases | Class II | Terminated |
| D-1740-2019 | 07-11-2019 | Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0 99528 35903 5); b) 4 OZ / 113 g (UPC 0 99528 31504 8); c) 16 OZ / 454 g (UPC 0 99528 31516 1); Manufactured For: Wonder Laboratories, 115 S.C.T. Ct., White House TN. 37188. | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 147 cases | Class II | Terminated |
| D-1736-2019 | 07-11-2019 | CVS Health Glycerin Suppositories, 100- count box, Distributed by:Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 42738 5 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 1174 cases | Class II | Terminated |
| D-1741-2019 | 07-11-2019 | CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01550 2 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 314 cases | Class II | Terminated |
| D-1724-2019 | 07-11-2019 | CVS Health Glycerin Suppositories, 50-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 33106 4 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 144 cases | Class II | Terminated |
| D-1729-2019 | 07-11-2019 | Adult Glycerin Suppositories, Package Size 50-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0441-50 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 196 cases | Class II | Terminated |
| D-1739-2019 | 07-11-2019 | Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52301 36504 3); c) 32 OZ/ 907 g (UPC 0 52301 36532 6); d) 16 OZ/ 454 g (UPC 0 52301 36516 6); e) 128 OZ/ 3629 g (UPC 0 52301 36512 8) Manufactured for: Dee Cee Laboratories, Inc. 304 Dee Cee Rd., White House, TN 37188. | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 2192 cases | Class II | Terminated |
| D-1727-2019 | 07-11-2019 | Children Glycerin Suppositories Laxative for ages 2 to 5. Package Size 25-count.Distributed by Walgreen CO. 200 Wilmot Rd. Deerfield IL 60015. NDC#0363-0440-25, | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 76 cases | Class II | Terminated |
| D-1490-2019 | 07-11-2019 | Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01. | Labeling: Missing label; Product complaints reported missing bottle label. | Lupin Pharmaceuticals Inc. / 17,238 bottles | Class III | Terminated |
| D-1734-2019 | 07-11-2019 | Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0638-04, UPC 3 11917 18247 6 Package NDCs: 0363-0638-02; 0363-0638-04 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 651 cases | Class II | Terminated |
| D-1728-2019 | 07-11-2019 | Adult Glycerin Suppositories, Package Size 25-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0445-25, Package NDCs: 0363-0445-25 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 98 cases | Class II | Terminated |
| D-1733-2019 | 07-11-2019 | Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0638-03, UPC 3 11917 18245 2 . Package NDCs: 0363-0638-01; 0363-0638-03 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 305 cases | Class II | Terminated |
| D-1735-2019 | 07-11-2019 | Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mundelein, IL 60060. NDC 53329-303-22 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 830 tubes | Class II | Terminated |
| D-1517-2019 | 07-11-2019 | Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02. Package NDCs: 27808-086-02; 27808-086-01; 27808-086-03 | Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives. | Tris Pharma Inc. / 2,550 bottles | Class II | Terminated |
| D-1731-2019 | 07-11-2019 | Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-03, UPC 3 11917 17935 3 Package NDCs: 0363-0620-01; 0363-0620-03 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 3114 cases | Class II | Terminated |
| D-1732-2019 | 07-11-2019 | Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-04, UPC 3 11917 17934 6 Package NDCs: 0363-0620-02; 0363-0620-04 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 1223 cases | Class II | Terminated |
| D-1630-2019 | 07-10-2019 | Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1 Package NDCs: 49035-330-45; 49035-330-02; 49035-330-96; 8113117595 | Microbial contamination of non-sterile product | LNK International, Inc. / P300456, P300475 and P300489 (Total - 13,500 liters) and P300482 - 3,600 liter | Class II | Terminated |
| D-1837-2019 | 07-09-2019 | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43 | Failed dissolution specifications : failed results at the 3-month stability time point. | Jubilant Cadista Pharmaceuticals, Inc. / 11,412 cartons/34,236 blister cards/28 tablets each card | Class I | Terminated |
| D-1487-2019 | 07-09-2019 | Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233. | Lack of Assurance of Sterility: Bags have the potential to leak. | Pfizer Inc. / 280340 bags | Class II | Terminated |
| D-1486-2019 | 07-09-2019 | Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028. | Lack of Assurance of Sterility: Bags have the potential to leak. | Pfizer Inc. / 58200 bags | Class II | Terminated |
| D-1742-2019 | 07-08-2019 | Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01 Package NDCs: 66794-151-01; 66794-155-01; 66794-155-02; 66794-156-01; 66794-156-02; 66794-157-01; 66794-157-02 | Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product. | Piramal Critical Care, Inc. / Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes) | Class II | Terminated |
| D-0355-2020 | 07-02-2019 | Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Net. Wt. 3.5 g (1/8 oz.), Rx only, Manufactured for Perrigo, Minneapolis, MN 55427, NDC 0574-4021-35 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 261,528 units | Class II | Completed |
| D-0357-2020 | 07-02-2019 | Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, Net Wt 3.5 g, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4190-35 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 41148 units | Class II | Completed |
| D-0352-2020 | 07-02-2019 | Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perrigo Minneapolis, MN 55427, NDC 0574-4160-35 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 1737549 containers | Class II | Completed |
| D-0354-2020 | 07-02-2019 | Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin zinc and hydrocortisone acetate) Ophthalmic Ointment USP, Net Wt. 3.5 g (1/8 oz), Rx only, Mfd. For Perrigo Minneapolis, MN 55427, NDC 0574-4144-35 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 87922 containers | Class II | Completed |
| D-0385-2020 | 07-02-2019 | CVS Health Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5 g), Item #247781, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0404-2020 | 07-02-2019 | CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 48,168 units | Class II | Completed |
| D-0463-2020 | 07-02-2019 | Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-103-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 41925 units | Class II | Completed |
| D-0435-2020 | 07-02-2019 | iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile, 1/3 FL OZ (10 mL), Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-143-10 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 12,716 units | Class II | Completed |
| D-0459-2020 | 07-02-2019 | Grandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL) Dist. By Grandall Distributing Co.Inc., Glendale, CA 91204-2707 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 73,548 units | Class II | Completed |
| D-0472-2020 | 07-02-2019 | Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10 mL, NDC 59390-144-51 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0450-2020 | 07-02-2019 | OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 81217 units | Class II | Completed |
| D-0420-2020 | 07-02-2019 | Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL, Rx only, Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-217-10 Package NDCs: 59390-217-02; 59390-217-05; 59390-217-10 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 636 units | Class II | Completed |
| D-0392-2020 | 07-02-2019 | CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 483528 units | Class II | Completed |
| D-0405-2020 | 07-02-2019 | CVS Health Fast Acting Lubricant Eye Drops Preservative Free, Item#: 994882, Product Size: 0.6 mL x 24 ct, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 58,704 units | Class II | Completed |
| D-0401-2020 | 07-02-2019 | CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, 10 mL, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0387-2020 | 07-02-2019 | CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Propylene Glycol 0.3%) Dry Eye Therapy, Sterile, 0.5 fl. oz. (15 mL), Item #895160, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 238,968 units | Class II | Completed |
| D-0365-2020 | 07-02-2019 | Equate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-875-50 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 441792 units | Class II | Completed |
| D-0456-2020 | 07-02-2019 | CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0442-2020 | 07-02-2019 | OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.5 fl oz (15 mL), Mfd. for: OCuSOFT Inc. PO Box 429 Richmond, TX 77406-0429, NDC 54799-503-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 75996 units | Class II | Completed |
| D-0434-2020 | 07-02-2019 | iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Tear Film Replenishment Mild Sterile, 0.5 FL OZ (15 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-13 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 4409 units | Class II | Completed |
| D-0376-2020 | 07-02-2019 | CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), Item #317914, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 531,936 units | Class II | Completed |
| D-0440-2020 | 07-02-2019 | OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 81403 units | Class II | Completed |
| D-0396-2020 | 07-02-2019 | CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 222096 units | Class II | Completed |
| D-0489-2020 | 07-02-2019 | Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz., UPC#: 6-78112-15418-7 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0443-2020 | 07-02-2019 | OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Single Dose (12/CT), Rx only, OCuSOFT, Inc. PO Box 492 Richmond TX 77406-0429 800-233-5469 Made in USA, Mfg. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-504-01 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 9518 units | Class II | Completed |
| D-0427-2020 | 07-02-2019 | iSolutions NanoTears HA Preservative Free Multi - Dose Lubricant Gel Drops Sterile, 0.33 FL OZ (10 mL), Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-208-10 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 137 units | Class II | Completed |
| D-0467-2020 | 07-02-2019 | Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 20666 units | Class II | Completed |
| D-0415-2020 | 07-02-2019 | Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY 111931, NDC 59390-181-13 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 306,479 units | Class II | Completed |
| D-0448-2020 | 07-02-2019 | OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 Made in USA, NDC 54799-565-59 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 296,314 units | Class II | Completed |
| D-0438-2020 | 07-02-2019 | ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF Sterile, 0.25 FL OZ (7.5 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-146-52 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 47 units | Class II | Completed |
| D-0451-2020 | 07-02-2019 | OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799-904-30 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 29326 units | Class II | Completed |
| D-0358-2020 | 07-02-2019 | Puralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, Net Wt. 1 g (NDC 0574-4025-11) and Net Wt. 3.5 g (1/8 oz.) (NDC 0574-4025-35), Manufactured for Perrigo, Minneapolis, MN 55427 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 195,864 unts | Class II | Completed |
| D-0474-2020 | 07-02-2019 | Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 195,864 units | Class II | Completed |
| D-0430-2020 | 07-02-2019 | iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free Multi-Dose Mild Dry Eye Therapy, 0.25 FL OZ (7.5 mL), Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-52 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 24 units | Class II | Completed |
| D-0374-2020 | 07-02-2019 | CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl. oz. (15 mL), Item #317916, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 365,832 units | Class II | Completed |
| D-0413-2020 | 07-02-2019 | CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 24,024 units | Class II | Completed |
| D-0417-2020 | 07-02-2019 | ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pharmaceuticals Inc., Aquebogue, NY 11931, NDC 59390-183-13 Package NDCs: 59390-183-13 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 22494 units | Class II | Completed |
| D-0454-2020 | 07-02-2019 | CVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Product Size: 2 x 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 50,304 units | Class II | Completed |
| D-0391-2020 | 07-02-2019 | CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5% Glycerin 1% Polysorbate 80 0.5%), Advanced Relief, 30 Sterile Single-Use Containers 0.02 fl. oz. (0.6 mL) each, Item #563442, NDC 50428 30295 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 48,168 units | Class II | Completed |
| D-0389-2020 | 07-02-2019 | CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #495301, NDC 50428 42216 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 77,760 units | Class II | Completed |
| D-0429-2020 | 07-02-2019 | iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-144-10 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 13,407 units | Class II | Completed |
| D-0386-2020 | 07-02-2019 | CVS Health Extra Strength Lubricant Gel Drops (Carboxymethyl-Cellulose Sodium 1%, Dry Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Item #799143, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 159,864 units | Class II | Completed |
| D-0449-2020 | 07-02-2019 | OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 427,280 units | Class II | Completed |
| D-0368-2020 | 07-02-2019 | Equate Night & Day Restore Tears Lubricant Eye Pack W-M item #: 567368000, Package Size: 3.5g and 15mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-883-59 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 55772 units | Class II | Completed |
| D-0390-2020 | 07-02-2019 | CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5%, Sensitive Solution, 70 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #457791, NDC 50428 41429 3, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 109,020 units | Class II | Completed |
| D-0470-2020 | 07-02-2019 | TRP Stye Relief, 4 g, NDC 17312-014-13 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 318,412 units | Class II | Completed |
