Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported February 6, 2019
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
H J Harkins Company Inc dba Pharma Pac recalled GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 1747… - a moderate-severity action.
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 1747… was recalled by H J Harkins Company Inc dba Pharma Pac in February 6, 2019. Reason: Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity te…. Check the official notice for the remedy. Verify recall #D-0415-2019 with the FDA Drug before acting.
The recall
H J Harkins Company Inc dba Pharma Pac issued this moderate-severity FDA Drug recall-Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity te….
- Moderate
- severity level
- Class II
- classification
- February 6, 2019
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0415-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0415-2019) was formally reported on February 6, 2019, with the manufacturer initiating the action on October 18, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. H J Harkins Company Inc dba Pharma Pac is listed as the recalling firm, operating out of Grover Beach, CA. Federal records list the affected scope as 84, 5 ml bottles.
The documented reason for this recall is: Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing. Distribution data in the federal record shows the product reached: Nationwide in the USA and Puerto Rico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
84, 5 ml bottles
Related Recalls
6
0 from same agency
Product description
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Reason for recall
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0415-2019 |
| Date reported | February 6, 2019 |
| Date initiated | October 18, 2018 |
| Recalling firm | H J Harkins Company Inc dba Pharma Pac |
| Firm location | Grover Beach, CA |
| Affected scope | 84, 5 ml bottles |
| Distribution | Nationwide in the USA and Puerto Rico |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0415-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00. Recalled by H J Harkins Company Inc dba Pharma Pac. Units affected: 84, 5 ml bottles.
Why was this product recalled? ▼
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 6, 2019. Severity: Moderate. Recall number: D-0415-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA and Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0415-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
AMASKY Nursing Pillows Recalled Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards fo…
Xishentang Dongguan Trading Co, Ltd., dba Pretty-Life, of China · 2026-07-02
CPSC Moderate
Diamond Wipes International Recalls CVS Health Medicated Hemorrhoidal Wipes Due to Risk of Serious Injury or Death from…
Diamond Wipes International, Inc. of Chino, California · 2026-07-02
CPSC Moderate
Junpower CR2032 Lithium Coin Batteries Recalled Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; V…
· 2026-07-02
CPSC Moderate
Target Recalls Gigglescape™ Under the Sea Popping Toy Due to Choking Hazard
· 2026-07-02
CPSC Moderate
Vevor Recalls Baby Loungers Due to Risk of Serious Injury or Death from Entrapment and Fall Hazards; Violate Mandatory …
Sanven Technology Ltd., dba Vevor, of Rancho Cucamonga, California · 2026-07-02
Compare this recall with AMASKY Nursing Pillows Recalled Due to Risk of Serious Inju… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported February 6, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.