Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc containe...

FDA Drug Recall #D-0927-2017 — Class II — June 1, 2017

Recall Summary

Recall Number D-0927-2017
Classification Class II — Moderate risk
Date Initiated June 1, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm American Pharmaceutical Ingredients LLC
Location Waterford, MI
Product Type Drugs
Quantity 23.5kg

Product Description

Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in 16 oz container (NDC: 58597-8082-6), c) 500 g packaged in a 2500 cc container (NDC: 58597-8082-7) and a 1,000 g packaged in 1 gallon container (NDC: 58597-8082-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Reason for Recall

Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.

Distribution Pattern

Nationwide in the US

Lot / Code Information

Lot: 082815-1, EXP 06/04/2019

Other Recalls from American Pharmaceutical Ingredients LLC

Recall # Classification Product Date
D-0592-2018 Class II Sermorelin Acetate, powder, a) 1 GM-bottle (NDC... Mar 7, 2018
D-0591-2018 Class II Oxytocin USP, powder, 1g-bottle, API American P... Mar 7, 2018
D-0503-2018 Class II Levocetirizine Dihydrochloride for prescription... Feb 9, 2018
D-0477-2018 Class II Calcipotriene BP (Monohydrate) for prescription... Feb 9, 2018
D-0526-2018 Class II Testosterone Cypionate USP (Micronized) for pr... Feb 9, 2018

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.