Denison Pharmaceuticals recalls Safe Tussin PM Nighttime Cough Relief due to use of non-food grade lubricant in mixing vessels, posing a potential contamination risk.
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Denison Pharmaceuticals is recalling Safe Tussin PM Nighttime Cough Relief bottles because they were made using non-food grade lubricant in the mixing process. This could lead to harmful contamination in the product.
The product was made using non-food grade lubricant in the mixing vessel, which could contaminate the cough relief medication. This poses a risk of harmful substances entering the medication.
People who purchased Safe Tussin PM Nighttime Cough Relief bottles from Kramer Laboratories, Inc. in Bridgewater, NJ. Those with the specific lot number 8639 (expiring 8/2023) are most at risk.
Check for Safe Tussin PM Nighttime Cough Relief bottles labeled with Kramer Laboratories, Inc. in Bridgewater, NJ. Look for the lot number 8639 that expires on 8/2023.
Look for the lot number 8639 on the bottle label, which expires on 8/2023.
The product was made with non-food grade lubricant, which could contaminate the medication. It is not safe to use as recalled.
The official recall notice does not specify a remedy, so check with Denison Pharmaceuticals for further instructions.
Check for Safe Tussin PM Nighttime Cough Relief bottles from Kramer Laboratories, Inc. in Bridgewater, NJ with lot number 8639 (expiring 8/2023).
We’ve drafted a message you can send Denison Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0775-2023 — Denison Pharmaceuticals Denison Pharmaceuticals Hello, I own a Denison Pharmaceuticals that is covered by recall D-0775-2023 from Denison Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
