Why it was recalled
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Product description
Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 .
Lot numbers, UPCs & expiration codes
Lot # 1446800; Exp. 03/15 Lot # 1538100; Exp. 05/15 Lot # 1538101; Exp. 05/15 Lot # 1538200; Exp. 06/15 Lot # 1608200; Exp. 08/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0385-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 28, 2015
- FDA report date
- Feb 18, 2015
- Quantity
- 23,449 jars
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0385-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70390
- Address
- 1925 W. Field Court, Suite 300
- Code information
- Lot # 1446800; Exp. 03/15 Lot # 1538100; Exp. 05/15 Lot # 1538101; Exp. 05/15 Lot # 1538200; Exp. 06/15 Lot # 1608200; Exp. 08/15
- Postal code
- 60045
- Report date
- Feb 18, 2015
- Product type
- Drugs
- Recall number
- D-0385-2015
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 23,449 jars
- Termination date
- Nov 30, 2017
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 .
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 28, 2015
- Initial firm notification
- Letter
- Center classification date
- Feb 10, 2015