Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless H...
FDA Drug Recall #D-1312-2019 — Class II — April 22, 2019
Recall Summary
| Recall Number | D-1312-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 22, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Inopak Ltd |
| Location | Ringwood, NJ |
| Product Type | Drugs |
| Quantity | 17,850 pounds per batch |
Product Description
Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with Aloe Vera & Vitamin E, packaged in a) 1000 ml Disc Pump pouches (NDC 58575-340), 8 x 1000 ml Disc Pump pouches per case, Product Code 5025-L1000; b) 2 fl. oz. bottles, 80/2 oz bottles per case, 5025-480-02; c) 18 fl. oz. bottles (NDC 58575-340), 16/18 oz bottles per case, 5025-430-02; d) 8 FL OZ. bottle, 24/8 oz bottle per case, 5025-440-03; e) 4 fl. oz. bottles, 24 x 4oz. Bottles per case, 5025-450-03; f) 800 ml pouches, 12 x 800 ml Universal Valve pouches per case, 5025-404-NB; g) 1 Gallon bottles, 4/1 gallon bottles per case, 5025-4202-02; Inopak LTD., Ringwood, NJ 07456. SaniTyze Hand Sanitizer with Aloe Vera, Vitamin E & Keratin, packaged as h) 8 fl oz (237 ml) bottles, 24/ 8 Oz. bottles per case; Manufactured for Crosstex International, Inc., 10 Rarick Road, Hauppague, NY 11788-4209.
Reason for Recall
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Distribution Pattern
Nationwide in the USA
Lot / Code Information
Batch #: 7069, 6648, 6649, 6652, 6654, 6667, 6669, 6675, 6677, 6684, 6686, 6692, 6694, 6703, 6704, 6710, 6717, 6719, 6726, 6727, 6731, 6733, 6739, 6743, 6748, 6751, 6752, 6759, 6763, 6767, 6769, 6771, 6775, 6776, 6780, 6782, 6787, 6788, 6801, 6805, 6808, 6811, 6814, 6815, 6821, 6824, 6825, 6830, 6831, 6836, 6843, 6845, 6852, 6859, 6860, 6874, 6878, 6880, 6881, 6884, 6889, 6897, 6900, 6903, 6905, 6912, 6920, 6922, 6926, 6928, 6931, 6940, 6945, 6948, 6951, 6954, 6962, 6967, 6969, 6972, 6975, 6980, 6986, 6989, 6995, 7002, 7015, 7023, 7029, 7030, 7035, 7044, 7047, 7048, 7051, 7059, 7062, 7066, 7072, 7073, 7079, 7081, 7084, 7085, 7088, 7090, 7095, 7096, 7099, 7102, 7105, 7112, 7113, 7115, 7124, 7125, and 7128.
Other Recalls from Inopak Ltd
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1317-2019 | Class II | Sani-Guard-SF Waterless Foam Hand Sanitizer, Et... | Apr 22, 2019 |
| D-1313-2019 | Class II | INODERM Antiseptic Hand Soap (E-2), .6% (incorr... | Apr 22, 2019 |
| D-1315-2019 | Class II | Antibacterial Hand Soap, Healthcare 2000, label... | Apr 22, 2019 |
| D-1316-2019 | Class II | Mild Health Care Antibacterial Hand Soap, .6% P... | Apr 22, 2019 |
| D-1310-2019 | Class II | ANTIBACTERIAL Foaming Hand Wash With Moisturize... | Apr 22, 2019 |
Frequently Asked Questions
cGMP stands for Current Good Manufacturing Practice — the FDA's regulations governing drug manufacturing quality. A cGMP recall means the company failed to follow required manufacturing standards. This could involve inadequate testing, poor environmental controls, documentation failures, or process deviations. cGMP recalls do not always mean the product is directly harmful — in many cases, quality records are insufficient to confirm the product meets specifications. However, the FDA requires a recall because without proper documentation, product quality cannot be assured. These are often Class II or Class III recalls.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.