Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bot...
FDA Drug Recall #D-1005-2020 — Class II — March 6, 2020
Recall Summary
| Recall Number | D-1005-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 6, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | H J Harkins Company Inc dba Pharma Pac |
| Location | Grover Beach, CA |
| Product Type | Drugs |
| Quantity | 11,973 tablets |
Product Description
Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bottles (NDC 52959-0002-45) and e) 50-count bottles (NDC 52959-0002-50) Repack: H.J. Harkins Co., Inc. Grover Beach, CA 93433
Reason for Recall
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle
Distribution Pattern
Nationwide within the United States
Lot / Code Information
Lot #: AE00M, exp. date 08/2021
Other Recalls from H J Harkins Company Inc dba Pharma Pac
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1246-2020 | Class II | Acetaminophen and Codeine Phosphate 300/30 mg t... | Apr 15, 2020 |
| D-0793-2020 | Class II | Ranitidine, 150 mg Tablets, a) 7 count, b) 14 c... | Jan 6, 2020 |
| D-1580-2019 | Class II | Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/... | Jul 12, 2019 |
| D-1429-2019 | Class II | Acetaminophen Children's Liquid, 160 mg/5 mL, 4... | Jun 24, 2019 |
| D-1430-2019 | Class II | Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz ... | Jun 24, 2019 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects 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.