Drug Recall: APAP 500 mg Phenyl HCl Tablets for CGMP Deviations
ULTRAtab Laboratories is recalling approximately 14.3 million tablets of APAP 500 mg Phenyl HCl 5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This recall is classified as FDA Class II with no reported illnesses or injuries. The hazard stems from manufacturing practice deviations rather than a known safety threat, making this a voluntary precautionary recall that merits a Moderate severity rating.
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, New York, is voluntarily recalling APAP 500 mg Phenyl HCl 5 mg tablets (containing Acetaminophen 500 mg and Phenylephrine HCl 5 mg) in bulk container form. The recall affects approximately 14,349,148 tablets and was initiated on January 26, 2022.
The recall was issued due to CGMP (Current Good Manufacturing Practice) deviations. The bulk product was distributed to 3 distributors, who may have further distributed finished product to downstream customers.
Affected lot numbers are: 18K017, 18L002, 19C064, 19E067, 19F064, 19H053, 19J023, and 19J051. The product code is C140L, and the NDC number is 62959-140-00.
Patients and healthcare providers in possession of affected product should discontinue use. Consumers with questions should contact their healthcare provider or pharmacist.
The recalled product
- Product
- APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Drug — Oral Tablet
- Hazard
- cgmp-deviations
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Product Codes: C140L Bulk Lots: 18K017
- 18L002
- 19C064
- 19E067
- 19F064
- 19H053
- 19J023
- 19J051
Distribution
Distribution scope not specified by the agency.
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