Class II · Moderate risk
Phenylephrine Hydrochloride Injectable Solution
cGMP deviations.
Chloresin
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2
Affected NDC
51532-0107-02
Compare with the code on your package — it is the most precise check available.
Drug: Phenylephrine Category: Pain Relief & OTC Medication
- Recalling firm
- Ultra Seal Corporation
- NDC code
- 51532-0107-2
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0468-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Phenylephrine recalls
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Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
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Class II · Moderate risk
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CGMP Deviations
Class III · Low risk
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Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk
PHENYLephrine HCl in 0.9% Sodium Chloride
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