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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Topical Products

Clindamycin Phosphate Topical Solution Recalled for Leaking Containers

Agency Publication Date: March 1, 2024
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Summary

Contract Pharmaceuticals Limited Canada is recalling 57,625 bottles of Clindamycin Phosphate (clindamycin phosphate) Topical Solution USP, 1% (60 mL) due to slow leakage from the containers. The recall involves specific lots manufactured for Marlex Pharmaceuticals and Glasshouse Pharmaceuticals after stability testing showed the bottles were leaking and falling below the required weight specifications. If you have this medication, contact your healthcare provider or pharmacist regarding the recall and return any unused portions to your place of purchase or contact the manufacturer.

Risk

The containers may leak slowly over time, which results in the product falling below its specified weight. While this defect is considered low risk, it can lead to a loss of medication volume and potential leakage onto other items.

What You Should Do

  1. This recall affects 60 mL bottles of Clindamycin Phosphate Topical Solution USP, 1% sold under the Marlex Pharmaceuticals (NDC 10135-0691-61) and Glasshouse Pharmaceuticals (NDC 71428-0003-60) brands.
  2. Check your bottle for NDC 10135-0691-61 and lot numbers 119466 (Exp 04/2025), 119467 (Exp 04/2025), 120351 (Exp 08/2025), or 121712 (Exp 11/2025).
  3. Check your bottle for NDC 71428-0003-60 and lot number 119874 (Exp 06/30/2025).
  4. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Clindamycin Phosphate Topical Solution USP, 1% (60 mL)by Marlex Pharmaceuticals
Variants: 1%, Topical Solution
Lot Numbers:
119466 (Exp 04/2025)
119467 (Exp 04/2025)
120351 (Exp 08/2025)
121712 (Exp 11/2025)
NDC:
10135-0691-61

Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720

Product: Clindamycin Phosphate Topical Solution USP, 1% (60 mL)by Glasshouse Pharmaceuticals
Variants: 1%, Topical Solution
Lot Numbers:
119874 (Exp 06/30/2025)
NDC:
71428-0003-60

Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94066
Status: Active
Manufacturer: Contract Pharmaceuticals Limited Canada
Sold By: Marlex Pharmaceuticals; Glasshouse Pharmaceuticals
Manufactured In: Canada
Units Affected: 2 products (45,875 bottles; 11,750 bottles)
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.