Diphenhydramine Liquid Recalled for Potential Microbial Contamination
H J Harkins Company is recalling Diphenhydramine HCL Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall involving microbial contamination, which aligns with the 'Severe' criteria for significant health risks.
Plain-English summary
H J Harkins Company Inc dba Pharma Pac is recalling 12 bottles of Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottles. The product was manufactured by Torrent Pharma, Inc., in Levittown, PA, and carries NDC 52959-0123-03. The specific lot number is DHI56M with an expiration date of 12/19.
The recall was initiated due to potential microbial contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii). The agency has classified this as a Class II recall. The product was distributed nationwide within the United States.
Consumers should check their inventory for the specific lot number and expiration date listed above. If they possess the affected product, they should stop using it and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
- Manufacturer
- H J Harkins Company Inc dba Pharma Pac
- Category
- Drug — Liquid Antihistamine
- Hazard
- Affected units
- 12
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 (2)
- Lot #: DHI56M
- Exp. 12/19
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by H J Harkins Company Inc dba Pharma Pac under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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