The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1429-2019·Announced 2019-07-03

Acetaminophen Children's Liquid Recalled for Microbial Contamination Risk

H J Harkins Company is recalling 40 bottles of Acetaminophen Children's 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 FDA classified this as a Class II recall involving potential microbial contamination with specific pathogens, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for adverse health consequences).

Plain-English summary

H J Harkins Company Inc dba Pharma Pac is recalling 40 bottles of Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle. The product was manufactured by Torrent Pharma, Inc. in Levittown, PA, and is identified by NDC 52959-0309-04. The recall covers specific lots: ACL75M (Exp. 02/20), ACL76M (Exp. 08/19), and ACL77M (Exp. 05/20).

The recall was initiated due to a potential risk of microbial contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii). The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected product was distributed nationwide within the United States. Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the place of purchase or disposed of according to local regulations.

The recalled product

Product
Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04
Manufacturer
H J Harkins Company Inc dba Pharma Pac
Category
Drug — Liquid Medication
Hazard
Affected units
40

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 (6)

  • Lot #: ACL75M
  • Exp. 02/20
  • ACL76M
  • Exp. 08/19
  • ACL77M
  • Exp. 05/20

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.

See all 2 products in this recall →

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