Why it was recalled
Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
Product description
Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60
Lot numbers, UPCs & expiration codes
Lot# 2530200, Expiration date: 1/31/2019. Lot# 2530300, Expiration date: 1/31/2019. Lot# 2530400, Expiration date: 1/31/2019. Lot# 2607300, Expiration date: 1/31/2019. Lot# 2607400, Expiration date: 1/31/2019. Lot# 2607500, Expiration date: 1/31/2019. Lot# 2607600, Expiration date: 1/31/2019. Lot# 2615800, Expiration date: 1/31/2019. Lot# 2630200, Expiration date: 2/28/2019. Lot# 2630300, Expiration date: 2/28/2019.
Where it was sold
Nationwide USA and Puerto Rico
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-1208-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 29, 2018
- FDA report date
- Dec 5, 2018
- Quantity
- 58,393 jars
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1208-2019, exactly as published.
Show all FDA fields
- City
- Decatur
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 81426
- Address
- 1222 W Grand Ave
- Code information
- Lot# 2530200, Expiration date: 1/31/2019. Lot# 2530300, Expiration date: 1/31/2019. Lot# 2530400, Expiration date: 1/31/2019. Lot# 2607300, Expiration date: 1/31/2019. Lot# 2607400, Expiration date: 1/31/2019. Lot# 2607500, Expiration date: 1/31/2019. Lot# 2607600, Expiration date: 1/31/2019. Lot# 2615800, Expiration date: 1/31/2019. Lot# 2630200, Expiration date: 2/28/2019. Lot# 2630300, Expiration date: 2/28/2019.
- Postal code
- 62522-1412
- Report date
- Dec 5, 2018
- Product type
- Drugs
- Recall number
- D-1208-2019
- Classification
- Class III
- Recalling firm
- Akorn, Inc.
- Product quantity
- 58,393 jars
- Termination date
- Aug 9, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Oct 29, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 23, 2019