CLASS III Drug recall · Reported 6 Sep 2023 · FDA Enforcement Report

Clindamycin Phosphate Topical Solution recalled

Contract Pharmaceuticals Limited Canada is recalling Clindamycin Phosphate Topical Solution USP, 1%, distributed nationwide in the US. The recall was initiated on 23 Aug 2023 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot # 118920, exp. January 2024.
Quantity recalled11,350 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-1139-2023
FDA event ID
92922
Recalling firm
Contract Pharmaceuticals Limited Canada, Mississauga, N/A
Classification
Class III
Status
Terminated
Recall initiated
23 Aug 2023
FDA classified
29 Aug 2023
Reported
6 Sep 2023
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Packaging Defects
Drug class
Antibiotics

Timeline

23 Aug 2023Recall initiated by company
29 Aug 2023Classified by FDA+6 days
6 Sep 2023Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Defective Container: slow leakage under the cap

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by: Contract Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, NDC# 71428-003-60

Where it was distributed

Nationwide in the USA.

Nationwide

Questions about this recall

Why was it recalled?

Defective Container: slow leakage under the cap

Which lots are affected?

Lot # 118920, exp. January 2024.

Where was it sold?

Nationwide in the USA.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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