Diphenhydramine HCL Liquid recall: Sterility Concern
Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
Why was Diphenhydramine HCL Liquid recalled?
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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?
Lot #: DHI56M, Exp. 12/19
- Product
- Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
- Quantity
- 12 bottles
- Distribution
- Nationwide Within the United States
- Recall date
- July 3, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)