Dologen 325 Caplet recall: CGMP Deviations
Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC…
Why was Dologen 325 Caplet recalled?
CGMP Deviations
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Codes: C121L Bulk Lots: 19G074, 19G075
- Product
- Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC…
- Recalling firm
- ULTRAtab Laboratories, Inc.
- Quantity
- 917,304 tablets
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- Recall date
- February 16, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)