Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 502...
FDA Drug Recall #D-0811-2016 — Class III — February 12, 2016
Recall Summary
| Recall Number | D-0811-2016 |
| Classification | Class III — Low risk |
| Date Initiated | February 12, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Apace KY LLC |
| Location | Fountain Run, KY |
| Product Type | Drugs |
| Quantity | 291 cartons |
Product Description
Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478.
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.
Distribution Pattern
All product was shipped to KY and further distributed Nationwide
Lot / Code Information
Outer Cases and Cartons Lot #: 13650, EXP 06/2017; Blisters Lot #: 13560, EXP 06/2017
Other Recalls from Apace KY LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0544-2018 | Class II | Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x... | Feb 9, 2018 |
| D-1035-2017 | Class II | Amantadine HCl Capsules, USP, 100 mg, Rx Only, ... | Jun 19, 2017 |
| D-1036-2017 | Class II | Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tabl... | Jun 19, 2017 |
| D-1683-2012 | Class III | Enalapril Maleate Tablet, USP 5mg 30 Tablet bot... | Sep 4, 2012 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
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.